Storage devices, loading devices, delivery systems, kits, and associated methods

ABSTRACT

Storage devices, loading devices, delivery systems, kits, and associated methods for implantable medical devices are described. An example embodiment of a storage device includes a storage member, a first cap, and a second cap. The storage member has a first end, a second end, and a main body that defines a first opening, a second opening, a passageway, a separating wall, and a plurality of holes. The passageway has a first portion and a second portion. The first portion extends from the first end of the storage member to the separating wall and the second portion extends from the second end of the storage member to the separating wall. Each hole of the plurality of holes extends through the separating wall and provides access between the first portion and the second portion. Each of the first and second caps is releasably attached to the storage member.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/694,660, filed on Jul. 6, 2018. The entire disclosure of this relatedapplication is hereby incorporated by reference into this disclosure.

FIELD

The disclosure relates generally to the field of medical devices. Moreparticularly, the disclosure relates to storage devices, loadingdevices, delivery systems, ancillary devices, kits, and associatedmethods for implantable medical devices.

BACKGROUND

Various implantable medical devices have been developed that provide amechanism for treating various disorders. For example, one potentialclinical application for an implantable valve is to treat chronic venousinsufficiency, in which the natural valves in the veins of the lowerextremities are incompetent, causing reflux, elevated venous pressuresand reduced blood flow. Another clinical application for an implantablevalve is to treat pulmonary insufficiency, which is a condition in whichthe pulmonary valve is incompetent and allows backflow from thepulmonary artery to the right ventricle of the heart. The implantablevalve can include a mechanical construct and a graft material. Incertain valve constructs, the valve graft material may require that theimplantable valve be stored in a wet condition to maintain the integrityof the graft material. For example, the implantable valve can be storedin a chemical solution, such as glutaraldehyde, which requires that thesolution be rinsed from the implantable valve prior to implantation. Theneed for rinsing is common practice in the bioprosthetic valve field.For example, when heart valves are stored in a solution, such asglutaraldehyde or formaldehyde, it is common practice that the valve beremoved from a storage container, rinsed in bowls of saline at thepatient's bedside, and loaded into the delivery system prior to theimplant procedure, which increases the likelihood of contamination ofthe implantable medical device.

Therefore, a need exists for new and useful storage devices, loadingdevices, delivery systems, ancillary devices, kits, and associatedmethods.

SUMMARY OF SELECTED EXAMPLE EMBODIMENTS

Various storage devices, loading devices, delivery systems, kits, andmethods are described herein.

An example storage device comprises a storage member, a first cap, and asecond cap. The storage member has a first end, a second end, and a mainbody that defines a first opening, a second opening, a passageway, aseparating wall, and a plurality of holes. The passageway extends fromthe first opening to the second opening and has a first portion and asecond portion. The separating wall extends into the passageway at alocation between the first end and the second end. The first portion ofthe passageway extends from the first end of the storage member to theseparating wall and the second portion of the passageway extends fromthe second end of the storage member to the separating wall. The secondportion is sized and configured to house an implantable medical device.Each hole of the plurality of holes extends through the separating walland provides access between the first portion of the passageway and thesecond portion of the passageway. The first cap is releasably attachedto the first end of the storage member. The second cap is releasablyattached to the second end of the storage member.

An example loading device comprises a storage member, a first cap, aloading member, and a second cap. The storage member has a first end, asecond end, and a main body that defines a first opening, a secondopening, a passageway, a separating wall, and a plurality of holes. Thepassageway extends from the first opening to the second opening and hasa first portion and a second portion. The separating wall extends intothe passageway at a location between the first end and the second end.The first portion of the passageway extends from the first end of thestorage member to the separating wall and the second portion of thepassageway extends from the second end of the storage member to theseparating wall. The second portion is sized and configured to house animplantable medical device. Each hole of the plurality of holes extendsthrough the separating wall and provides access between the firstportion of the passageway and the second portion of the passageway. Thefirst cap is releasably attached to the first end of the storage member.The loading member is releasably attached to the second end of thestorage member and has a first end, a second end, and a main body thatdefines a first opening, a second opening, and a passageway that extendsfrom the first opening to the second opening. The passageway of theloading member has a first portion, a second portion, a third portion,and a fourth portion. The first portion of the passageway of the loadingmember extends from the first end of the loading member to the secondportion of the passageway of the loading member and has a first insidediameter. The second portion of the passageway of the loading memberextends from the first portion of the passageway of the loading memberto the third portion of the passageway of the loading member and has asecond inside diameter that tapers from the first portion of thepassageway of the loading member to the third portion of the passagewayof the loading member. The third portion of the passageway of theloading member extends from the second portion of the passageway of theloading member to the second end of the loading member and has a thirdinside diameter that is less than the first inside diameter of the firstportion of the passageway of the loading member. The fourth portion ofthe passageway of the loading member extends from the third portion andhas a width that is greater than the third inside diameter of the thirdportion of the passageway. The second cap is releasably attached to thesecond end of the loading member.

An example delivery system comprises a sheath, an elongate member, atip, and a gripping member. The sheath has a first end, a second end, alength, and a main body that defines a lumen. The length of the sheathextends from the first end to the second end. The lumen extends throughthe entire length of the sheath. The elongate member has a lengthwiseaxis, a first end, a second end, and a main body that defines an outersurface, and a notch. The notch extends into the main body of theelongate member from the outer surface, toward the lengthwise axis, andtoward the second end of the elongate member at an angle that is greaterthan 0 degrees relative to the lengthwise axis. The tip is disposed onthe second end of the elongate member and has a first end and a secondend. The gripping member is attached to the elongate member between thenotch and the first end of the tip. The gripping member has a first end,a second end, a length, and a main body. The gripping member is sizedand configured to be disposed within the sheath. The notch is disposedbetween the first end of the elongate member and the gripping member.

An example kit comprises a storage device, a device guard, a deliverysystem, and a loading member. The storage device comprises a storagemember, a first cap, and a second cap. Another example kit comprises aloading device, a device guard, and a delivery system. The loadingdevice comprises a storage member, a first cap, a loading member, and asecond cap.

An example method of sterilizing an implantable medical devicecomprises: inserting an implantable medical device into a storagemember; attaching a first cap to the storage member; introducing asterilizing material into the storage member; introducing a holdingmaterial into the storage member such that the sterilizing material isremoved from the storage member; attaching a second cap to the storagemember.

An example method of storing an implantable medical device comprises:inserting a sterilized implantable medical device into a storage member;attaching a first cap to the storage member; introducing a holdingmaterial into the storage member; attaching a second cap to the storagemember.

An example method of rinsing an implantable medical device comprises:attaching a device that includes a rinsing material to a one-way valveof a storage device; introducing the rinsing material into the storagedevice such that it passes through the storage device; stopping the stepof introducing the rinsing material into the storage device.

An example method of loading an implantable medical device onto adelivery system comprises: removing a cap from a storage membercontaining an implantable medical device; removing a diffuser from thestorage member; attaching a device guard to the storage member; removinga second cap; attaching the storage member to a loading member of aguide system; applying an axial force on a portion of a delivery systemsuch that it is passed through the storage member and partially disposedwithin the device guard; positioning a loading puller within a notchdefined by an elongate member of the delivery system; applying an axialforce on the elongate member of the delivery system away from thestorage member until the loading puller moves to its open configurationand is free of the implantable medical device; removing the loadingpuller from the delivery system and loading member; applying an axialforce on a sheath of the delivery system toward the loading member whilemaintaining the position of the elongate member until the sheathcontacts the loading member; applying an axial force on the elongatemember while maintaining the position of the sheath such that theelongate member is withdrawn from the loading member and the medicaldevice is advanced into the sheath; removing the delivery system fromthe loading member.

Another example method of loading an implantable medical device onto adelivery system comprises: removing a cap from a storage membercontaining an implantable medical device; removing a diffuser from thestorage member; attaching a device guard to the storage member; applyingan axial force on a portion of a delivery system such that it is passedthrough the storage member and partially disposed within the deviceguard; positioning a loading puller within a notch defined by anelongate member of the delivery system; applying an axial force on theelongate member of the delivery system until the loading puller moves toits open configuration and is free of the implantable medical device;removing the loading puller from the delivery system and loading member;applying an axial force on a sheath of the delivery system toward theloading member while maintaining the position of the elongate memberuntil the sheath contacts the loading member; applying an axial force onthe elongate member while maintaining the position of the sheath suchthat the elongate member is withdrawn from the loading member and themedical device is advanced into the sheath; removing the delivery systemfrom the loading member.

Another example method of loading an implantable medical device onto adelivery system comprises: obtaining an implantable medical device withan attached loading puller; removing the implantable medical device andloading puller from the container; rinsing the implantable medicaldevice and loading puller; advancing a loading assister through apassageway defined by a loading member; attaching the loading assisterto the loading puller; withdrawing the loading assister from the loadingmember; removing the loading assister from the loading puller; attachinga device guard to the loading member; applying an axial force on anelongate member of a delivery system directed toward a loading membersuch that it is passed through the loading member and partially disposedwithin the device guard; positioning a loading puller within a notchdefined by an elongate member of the delivery system; applying an axialforce on the elongate member of the delivery system directed away fromthe loading member until the first and second ends of the loading pullerare disposed within the fourth portion of the loading member; removingthe loading puller from the delivery system and loading member; applyingan axial force on a sheath of the delivery system directed toward theloading member while maintaining the position of the elongate memberuntil the sheath contacts the loading member; applying an axial force onthe elongate member directed away from the loading member whilemaintaining the position of the sheath such that the elongate member iswithdrawn from the loading member and the medical device is advancedinto the sheath; removing the delivery system from the loading member.

Additional understanding of the example storage devices, loadingdevices, delivery systems, ancillary devices, kits, and associatedmethods can be obtained by review of the detailed description, below,and the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded cross-sectional view of a first example storagedevice taken along the lengthwise axis of the storage member.

FIG. 2 is an end view of the storage member illustrated in FIG. 1.

FIG. 3 is a perspective view of the storage member illustrated in FIG.1.

FIG. 4 is a partial cross-sectional view of a second example storagedevice taken along the lengthwise axis of the storage member.

FIG. 5 is a perspective view of the device guard illustrated in FIG. 4.

FIG. 6 is an exploded cross-sectional view of a third example storagedevice taken along the lengthwise axis of the storage member.

FIG. 7 is a perspective view of the storage member illustrated in FIG.6.

FIG. 8 is an exploded perspective view of a fourth example storagedevice.

FIG. 9 is an exploded cross-sectional view of the storage deviceillustrated in FIG. 8 taken along the lengthwise axis of the storagemember.

FIG. 10 is an end view of the storage member illustrated in FIG. 8.

FIG. 11 is a perspective view of the storage member illustrated in FIG.8.

FIG. 12 is a magnified view of area I-I illustrated in FIG. 11.

FIG. 13 is a perspective view of the diffuser illustrated in FIG. 8.

FIG. 14 is another perspective view of the diffuser illustrated in FIG.8.

FIG. 15 is an elevation view of a fifth example storage device.

FIG. 16 is a cross-sectional view of the storage device illustrated inFIG. 15 taken along the lengthwise axis of the storage member.

FIG. 16A is a top view of the loading puller illustrated in FIG. 16.

FIG. 16B is a partial top view of a loading puller attached to animplantable medical device.

FIG. 17 is a partially exploded cross-sectional view of a first exampleloading device taken along the lengthwise axis of the loading member.

FIG. 18 is an elevation view of a second example loading device.

FIG. 19 is an exploded cross-sectional view of the loading deviceillustrated in FIG. 18 taken along the lengthwise axis of the storagemember.

FIG. 20 is a perspective view of the loading member illustrated in FIG.18.

FIG. 21 is another perspective view of the loading member illustrated inFIG. 18.

FIG. 22 is an end view of the loading member illustrated in FIG. 18.

FIG. 23 is an end view of the second cap illustrated in FIG. 18.

FIG. 24 is a perspective view of the storage member illustrated in FIG.18.

FIG. 25 is a perspective view of the first cap illustrated in FIG. 18.

FIG. 26 is a perspective view of the connector illustrated in FIG. 18.

FIG. 27 is a partial elevation view of a first example delivery system.

FIG. 28 is a magnified view of area II-II illustrated in FIG. 27.

FIG. 29 is a partial elevation view of a second example delivery system.

FIG. 30 is a partial perspective view of a third example deliverysystem.

FIG. 31 is a perspective view of an alternative tip that can be includedon an elongate member of a delivery system.

FIG. 32 is an elevation view of the tip illustrated in FIG. 31.

FIG. 32A is a perspective view of another alternative tip that can beincluded on an elongate member of a delivery system.

FIG. 32B is an end view of the tip illustrated in FIG. 32A.

FIG. 32C is a perspective view of an alternative device guard that canbe included on a storage device or loading device.

FIG. 32D is an end view of the device guard illustrated in FIG. 32C.

FIG. 33 is a perspective view of an example guide system.

FIG. 34 is a top view of the guide board illustrated in FIG. 33.

FIG. 35 is a perspective view of a portion of the loading memberillustrated in FIG. 33.

FIG. 35A is a perspective view of another portion of the loading memberillustrated in FIG. 33.

FIG. 36 is a perspective view of a portion of the guide memberillustrated in FIG. 33.

FIG. 36A is a perspective view of another portion of the guide memberillustrated in FIG. 33.

FIG. 37 illustrates an example kit that includes a storage device.

FIG. 38 illustrates an example kit that includes a loading device.

FIG. 39 is a schematic illustration of an example method of sterilizingan implantable medical device.

FIG. 40 is a cross-sectional view of an implantable medical devicestored within an example storage member.

FIG. 41 is a schematic illustration of another example method ofsterilizing an implantable medical device.

FIG. 42 is a cross-sectional view of an implantable medical devicestored within an example storage member.

FIG. 43 is a schematic illustration of an example method storing animplantable medical device.

FIG. 44 is a schematic illustration of an example method of rinsing animplantable medical device.

FIG. 45 is a schematic illustration of an example method of loading animplantable medical device onto a delivery system.

FIG. 46 is a cross-sectional view of a storage member attached to aloading member of a guide system.

FIG. 46A is a magnified view of area III-III illustrated in FIG. 46.

FIG. 47 is a cross-sectional view of a delivery system partiallydisposed within a device guard and a loading puller disposed within anotch defined by an elongate member.

FIG. 47A is a magnified view of area IV-IV illustrated in FIG. 47.

FIG. 48 is a cross-sectional view of a loading puller in an openconfiguration.

FIG. 48A is a magnified view of area V-V illustrated in FIG. 48.

FIG. 49 is a cross-sectional view of a sheath contacting the loadingmember.

FIG. 49A is a magnified view of area VI-VI illustrated in FIG. 49.

FIG. 50 is a schematic illustration of another example method of loadingan implantable medical device onto a delivery system.

FIG. 51 is a cross-sectional view of a delivery system partiallydisposed within a device guard and a loading puller disposed within anotch defined by an elongate member.

FIG. 51A is a magnified view of area VII-VII illustrated in FIG. 51.

FIG. 52 is a cross-sectional view of a delivery system partiallydisposed within a device guard and a loading puller disposed within anotch defined by an elongate member. The loading puller is in an openconfiguration.

FIG. 52A is a magnified view of area VIII-VIII illustrated in FIG. 52.

FIG. 53 is a cross-sectional view of a delivery system partiallydisposed within a device guard and a sheath contacting a loading member.

FIG. 53A is a magnified view of area IX-IX illustrated in FIG. 53.

FIG. 54 is a partial perspective view of a fourth example deliverysystem.

FIG. 55 is a perspective view of an alternative device guard that can beused with a loading member.

FIG. 56 is a perspective view of an example loading assister.

FIG. 57 is a partial elevation view of the loading assister illustratedin FIG. 56.

FIG. 58 a top view of another example loading puller.

FIG. 59 is an elevation view of the loading puller illustrated in FIG.58.

FIG. 60 is a top view of the loading puller illustrated in FIG. 58attached to an implantable medical device.

FIG. 61 is a perspective view of another example loading member.

FIG. 62 is an end view of the loading member illustrated in FIG. 61.

FIG. 63 is another end view of the loading member illustrated in FIG.61.

FIG. 64 is a cross-sectional view of the loading member illustrated inFIG. 61 taken along the lengthwise axis of the loading member.

FIG. 65 is another cross-sectional view of the loading memberillustrated in FIG. 61 taken along the lengthwise axis of the loadingmember.

FIG. 66 is another cross-sectional view of the loading memberillustrated in FIG. 61 taken along the lengthwise axis of the loadingmember.

FIG. 67 is a schematic illustration of another example method of loadingan implantable medical device onto a delivery system.

FIG. 68 illustrates a loading assister partially disposed through aloading member and releasably attached to a loading puller that is freeof the loading member. An implantable medical device is releasablyattached to the loading puller.

FIG. 69 illustrates a loading assister free of a loading member andreleasably attached to a loading puller partially disposed within theloading member. An implantable medical device is releasably attached tothe loading puller and is entirely disposed within the loading member.

FIG. 70 illustrates a loading puller partially disposed within theloading member. An implantable medical device is releasably attached tothe loading puller and is entirely disposed within the loading member. Adevice guard is releasably attached to the loading member.

FIG. 71 illustrates a loading puller partially disposed within theloading member and disposed within a notch defined by an elongate memberof a delivery system. An implantable medical device is releasablyattached to the loading puller and is entirely disposed within theloading member. A device guard is releasably attached to the loadingmember.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various example embodiments of storage devices, loadingdevices, delivery systems, ancillary devices, kits, and methods. Thedescription and illustration of these examples are provided to enableone skilled in the art to make and use a storage device, a loadingdevice, a delivery system, an ancillary device, to make a kit, and topractice a method. They are not intended to limit the scope of theclaims in any manner.

As used herein, the term “diameter” refers to the length of a straightline passing from side to side through the center of a body, element, orfeature, and does not impart any structural configuration on the body,element, or feature.

As used herein, the term “circumferential” refers to an enclosingboundary of a body, element, or feature, and does not impart anystructural configuration on the body, element, or feature.

FIGS. 1, 2, and 3 illustrate a first example storage device 10 thatincludes a storage member 12, a first cap 14, and a second cap 16. Inthe illustrated embodiment, each of the first cap 14 and the second cap16 is releasably attached to the storage member 12.

The storage member 12 has a lengthwise axis 13, a first end 20, a secondend 22, and a main body 24 that defines a circumferential wall 26, afirst opening 28, a second opening 30, a passageway 32, a separatingwall 34, and a plurality of holes 36. The passageway 32 extends throughthe storage member 12 from the first opening 28 to the second opening 30and has a first portion 38 that extends from the first end 20 to theseparating wall 34 and a second portion 40 that extends from the secondend 22 to the separating wall 34. The first portion 38 has a firstinside diameter 39. The second portion 40 has a second inside diameter41 at the separating wall 34 that is less than the first inside diameter39 and a third inside diameter 43 at the second end 22 that is equal tothe first inside diameter 39 such that the second portion 40 tapers fromthe second end 22 to the separating wall 34 (e.g., creating a partialcone). In the illustrated embodiment, the second portion 40 is sized andconfigured to house an implantable medical device, as described in moredetail herein. The separating wall 34 extends into the passageway 32 ata location between the first end 20 and the second end 22 that ispositioned closer to the first end 20. The separating wall 34 defines athrough hole 42 that has inside diameter 45 that is less than the secondinside diameter 41 of the second portion 40. Each hole of the pluralityof holes 36 extends through the separating wall 34 and provides accessbetween the first portion 38 of the passageway 32 and the second portion40 of the passageway 32 such that a fluid passed through the storagemember 12 can pass through the through hole 42 and/or the plurality ofholes 36 over the outside and inside surfaces of a medical devicedisposed within the second portion of the passageway 40. Each hole ofthe plurality of holes 36 is equally spaced from an adjacent hole of theplurality of holes 36 and is disposed the same distance from thecircumferential wall 26 relative to the other holes of the plurality ofholes 36.

While the storage member 12 has been illustrated as having a particularstructural arrangement, a storage member can have any suitablestructural arrangement and selection of a suitable structuralarrangement for a storage member can be based on various considerations,including the type of implantable medical device intended to be storedwithin the storage member. For example, while the passageway 32 has beenillustrated as having a first portion 38 and a second portion 40, apassageway defined by a main body of a storage member can have anysuitable number of portions, such as one, at least one, two, aplurality, three, four, and any other number considered suitable for aparticular embodiment. While the second portion 40 has been illustratedas having a second inside diameter 41 at the separating wall 34 that isless than the first inside diameter 39 and a third inside diameter 43 atthe second end 22 that is equal to the first inside diameter 39, asecond portion can have any suitable inside diameters. For example, asecond portion can have a second inside diameter at the separating wallthat is equal to, less than, greater than, or about a first insidediameter of a first portion and/or a third inside diameter at a secondend that is equal to, less than, greater than, or about the first insidediameter. While the separating wall 34 has been illustrated aspositioned closer to the first end 20, a separating wall can bepositioned at any suitable location between the first and second ends ofa storage member. For example, a separating wall can be disposed in thecenter of a storage member between first and second ends, or positionedcloser to a second end of a storage member. While the storage member 12has been illustrated as defining a plurality of holes 36 such that eachhole of the plurality of holes 36 is equally spaced from an adjacenthole of the plurality of holes 36 and is disposed the same distance fromthe circumferential wall 26 relative to the other holes of the pluralityof holes 36, a storage member can include any suitable number of holespositioned in any suitable orientation. Examples of numbers of holesconsidered suitable for a main body of a storage member to define on aseparating wall include one, at least one, two, a plurality, three,four, five, more than five, more than ten, and any other numberconsidered suitable for a particular embodiment. Examples of positionsconsidered suitable to locate a plurality of holes include such thateach hole of a plurality of holes is equally spaced, or irregularlyspaced, from an adjacent hole of the plurality of holes and is disposedthe same distance, or a varied distance, from a circumferential wallrelative to the other holes of the plurality of holes.

Each of the first cap 14 and the second cap 16 is sized and configuredto be releasably attached to the storage member 12. The first cap 14 isreleasably attached to the first end 20 of the storage member 12 and thesecond cap 16 is releasably attached to the second end 22 of the storagemember. When attached to the storage member 12, each of the first cap 14and the second cap 16 seals the passageway 32 defined by the storagemember 12. In the illustrated embodiment, each of the first cap 14 andthe second cap 16 defines threads that mate with threads defined by thestorage member 12 to achieve releasable attachment between the storagemember 12 and the first and second caps 14, 16.

While the first cap 14 has been illustrated as being threadably attachedto the storage member 12 and the second cap 16 has been illustrated asbeing threadably attached to the storage member 12, a first cap and asecond cap can be attached to a storage member using any suitabletechnique or method of attachment and selection of a suitable techniqueor method of attachment between the cap and a storage member can bebased on various considerations, including the material(s) that formsthe cap and/or storage member. Examples of techniques and methods ofattachment considered suitable between a cap and a storage member,between a storage member and any other component, between a loadingmember and any other component, and/or between any two componentsdescribed herein include using threaded connections, threadedconnections using a thread disposed on an exterior surface of a storagemember to avoid rotation of the storage member (e.g., to avoiddisruption of an implantable medical device stored in the storage deviceduring attachment of a cap), snap fit attachments, using one or moreconnectors, one or more mating slots and projections, one or more sealedunions, tapered attachments (e.g., morse taper), and any other techniqueor method of attachment considered suitable for a particularapplication.

FIGS. 4 and 5 illustrate another example storage device 110. The storagedevice 110 is similar to the storage device 10 illustrated in FIGS. 1,2, and 3 and described above, except as detailed below. The storagedevice 110 includes a storage member 112, a first cap 114, and a secondcap 116. In the illustrated embodiment, each of the first cap 114 andthe second cap 116 defines structure that mates with structure definedby the storage member 112 to achieve a releasable snap fit attachmentbetween the storage member 112 and the first and second caps 114, 116.

In the illustrated embodiment, the storage member 112 includes a port121 extending from the main body 124 and a first two-way valve 123attached to the port 121. In addition, the second cap 116 defines apassageway 125 that extends through the main body of the second cap 116that is in communication with a second two-way valve 127. Thisstructural arrangement provides a mechanism for sterilizing and/orrinsing an implantable medical device stored in the storage device 110,decreasing the complexity of sterilizing, storing, rinsing, and/orloading an implantable medical device, and minimizing the riskassociated with handling an implantable medical device that is intendedto be positioned within the storage device. In an alternativeembodiment, the port 121, the first two-way valve 123, the passageway125, and/or the second two-way valve 127 can be omitted.

In the illustrated embodiment, the first cap 114 comprises a deviceguard 146 that is releasably attached to the first end 120 of thestorage member 112 and partially extends into the passageway 132 definedby the storage member 112. The device guard 146 has a lengthwise axis147, a first end 148, a second end 150, and a main body 152 that definesa base 154, a first projection 156, a second projection 158, and arecess 160. The base 154 is disposed between the first end 148 and thesecond end 150 and is sized and configured to be releasably attachedwithin the passageway 132 of the storage member 112. In the illustratedembodiment, the base 154 has an outside diameter 155, a first side 162,a second side 164, and is sized and configured to be releasably attachedto the storage member 112 within the passageway 132 using a snap fitattachment between the device guard 146 and the storage member 112.Thus, the storage member 112 and the device guard 146 define matingstructure that achieves a releasable snap fit attachment between thestorage member 112 and the device guard 146.

The first projection 156 extends from the first side 162 to the firstend 148 and the second projection 158 extends from the second side 164to the second end 150. The first projection 156 has an outside diameter157 that tapers from the base 154 to the first end 148, which provides amechanism for positioning an implantable medical device between thefirst projection 156 and the storage member 112. The second projection158 has a first outside diameter 149 at the base 154, a second outsidediameter 151 between the base 154 and the second end 150, and a thirdoutside diameter 153 at the second end 150. The second outside diameter151 is less than the first outside diameter 149 and the third outsidediameter 153 is less than the second outside diameter 151. The recess160 extends from the first end 148 toward the second end 150 to a recessbase 166 and is sized and configured to receive a portion of a deliverysystem, as described in more detail herein. The recess 160 has a firstportion 168, a second portion 170, and a third portion 172. The firstportion 168 has an inside diameter 167 that increases from the first end148 to the second portion 170. The second portion 170 has an insidediameter 169 that tapers from the first portion 168 to the third portion172. The third portion 172 has an inside diameter 171 that is less thanthe inside diameter 169 of the second portion 170. Each of the firstportion 168 and the second portion 170 has a partial conicalconfiguration and the third portion 172 is sized and configured to matewith a portion of a delivery system (e.g., tip 1516) such that theportion of the delivery system is rotationally fixed relative to thedevice guard 146 when disposed within the third portion 172, asdescribed in more detail herein. In the illustrated embodiment, thethird portion 172 defines a planar surface 173 that extends from thesecond portion 170 to the recess base 166 that is sized and configuredto mate with a portion of a tip (e.g., planar surface 1572 of tip 1516)of a delivery system, as described in more detail herein. When attachedto the storage member 112, the device guard 146 is positioned such thatthe first projection 156 extends through the through hole 142 of theseparating wall 134. During use, the device guard 146 acts as amechanical stop to advancement of a delivery system through a storagemember, as described in more detail herein.

While the device guard 146 has been illustrated as having a particularstructural arrangement, a device guard can have any suitable structuralarrangement and selection of a suitable structural arrangement for adevice guard can be based on various considerations, including the typeof implantable medical device intended to be implanted using a storagedevice of which the device guard is a component. For example, while thedevice guard 146 has been illustrated as a single component, a deviceguard can be formed as multiple components (e.g., base, firstprojection, second projection) releasably attached, or fixedly attached,to one another, a first projection can have a constant outside diameteralong its length, a second projection can have a constant outsidediameter along its length, and/or a first portion can have an insidediameter that is constant from first end to second portion. While eachof the first portion 168 and the second portion 170 has been illustratedas having a partial conical configuration and the third portion 172 hasbeen illustrated as having a planar surface 173 that extends from thesecond portion 170 to the recess base 166, a recess defined by a deviceguard can have any suitable configuration. For example, a recess candefine any structural arrangement that is sized and configured toreceive any suitable portion of a delivery system (e.g., portion of atip, entire tip) and/or rotationally fix a portion of a delivery systemrelative to the device guard when disposed within the device guard.While device guard 146 has been illustrated as being releasably attachedto storage member 112, any suitable device guard, such as thosedescribed herein (e.g., device guard 715, device guard 1714), can bereleasably attached to a storage member.

FIGS. 6 and 7 illustrate another example storage device 210. The storagedevice 210 is similar to the storage device 10 illustrated in FIGS. 1,2, and 3 and described above, except as detailed below. The storagedevice 210 includes a storage member 212, a first cap 214, and a secondcap 216.

In the illustrated embodiment, the second portion 240 has a secondinside diameter 241 at the separating wall 234 that is equal to thefirst inside diameter 239 such that the second portion 240 has aconstant inside diameter 241 from the separating wall 234 to the secondend 222 (e.g., creating a cylinder). In addition, each hole of theplurality of holes 236 defined by the main body 224 of the storagemember 212 is not equally spaced from an adjacent hole of the pluralityof holes 236 and is disposed a different distance from thecircumferential wall 226 relative to the other holes of the plurality ofholes 236. The main body 224 of the storage member 212 defines first andsecond projections 276, 278 that extend from the circumferential wall226, a first passageway 280 that extends through the first projection276, and a second passageway 282 that extends through the secondprojection 278. The projections 276, 278 and the passageways 280, 282are sized and configured to mate with a loading member and/or guidemember, as described in more detail herein, such that the storage member212 can be releasably attached to the loading member and/or guidemember. While the storage member 212 has been illustrated as including aspecific structural arrangement to accomplish releasable attachment to aloading member and/or guide member, any suitable structure can be usedto accomplish such a releasable attachment. Any embodiment of a storagemember described herein can optionally include one or more projections(e.g., projections 276, 278) and one or more passageways (e.g.,passageways 280, 282) such that the storage member can releasablyattached to a loading member and/or guide member and be used with aguide system, as described in more detail herein.

In the illustrated embodiment, the second cap 216 is releasably attachedto the second end 222 of the storage member 212. The second cap 216 hasa lengthwise axis 283, a first end 284, a second end 286, and a mainbody 288 that defines a recess 290 that extends into the second cap 216.The recess 290 has a first portion 292, a second portion 294, andextends to a recess base 296. The first portion 292 extends from thefirst end 284 toward the second end 286 and has a first inside diameter291. The second portion 294 extends from the first portion 292 to therecess base 296 and has a second inside diameter 293 that tapers fromthe first portion 292 to the recess base 296.

FIGS. 8, 9, 10, 11, 12, 13, and 14 illustrate another example storagedevice 310. The storage device 310 is similar to the storage device 210illustrated in FIGS. 6 and 7 and described above, except as detailedbelow. The storage device 310 includes a storage member 312, a first cap314, a second cap 316, a first one-way valve 410, a second one-way valve412, and a diffuser 414.

In the illustrated embodiment, the inside diameter of the second portion340 of the storage member 312 has a second inside diameter 341 at theseparating wall 334 that positions the circumferential wall 326 in thesecond portion 340 of the passageway 332 such that it partiallyobstructs the plurality of holes 336. As shown FIGS. 10, 11, and 12 themain body 324 of the storage member 312 defines a plurality of recesses416. Each recess of the plurality of recesses 416 extends into thecircumferential wall 326 to a recess base 418 and extends from theseparating wall 334 toward the second end 322. In the illustratedembodiment, each recess of the plurality of recesses 416 extends to thesecond end 322. Each recess of the plurality of recesses 416 is incommunication with a hole of the plurality of holes 336 and has a firstwidth 415 at the separating wall 334 at the recess base 418 and a secondwidth 417 between the separating wall 334 and the second end 322 at therecess base 418 that is greater than the first width 415. By positioningeach recess of the plurality of recesses 416 such that it is adjacent toand in communication with a hole of the plurality of holes 336, fluidpassed through the storage member 312 from the first one-way valve 410toward the second one-way valve 412 can flow through the plurality ofholes 336 and within the plurality of recesses 416 to increase theamount of fluid that contacts any implantable medical device disposedwithin the storage member 312. The through hole 342 defined by the mainbody 324 of the storage member 312 is sized and configured to receive aportion of the diffuser 414, as described in more detail herein.

While each recess of the plurality of recesses 416 has been illustratedas extending from the separating wall 334 to the second 322, as being incommunication with a hole of the plurality of holes 336, and having afirst width 415 at the separating wall 334 at the recess base 418 and asecond width 417 between the separating wall 334 and the second end 322at the recess base 418 that is greater than the first width 415, eachrecess can have any suitable structural arrangement. Selection of asuitable structural arrangement for each recess included in a storagemember can be based on various considerations, including the structuralarrangement of an implantable medical device intended to be disposedwithin the storage member. For example, a storage member can define anysuitable number of recesses, such as one, at least one, two, aplurality, three, four, five, more than five, more than ten, and anyother number considered suitable for a particular embodiment. A recessincluded on a storage member can extend any suitable length of a storagemember. For example, a recess, or each recess of a plurality ofrecesses, can extend from a separating wall to a second end of a storagemember, from a separating wall to a location between the separating walland the second end, from a location between a separating wall and asecond end to the second end, from a first location between a separatingwall and a second end to a second location between the first locationand the second end, and any other length of a storage member consideredsuitable for a particular embodiment. A recess included on a storagemember can have any suitable width along its length. For example, arecess, or each recess of a plurality of recesses, can have a firstwidth at a first end (e.g., at a separating wall) at a recess base and asecond width at a second end (e.g., between a separating wall and asecond end) at a recess base that is greater than, less than, equal to,or about the first width. A recess included on a storage member can haveany suitable structural arrangement, such as curved, cuboidal,prismatic, and any other structural arrangement considered suitable fora particular embodiment.

In the illustrated embodiment, the second cap 316 is releasably attachedto the second end 322 of the storage member 312. The passageway 390 ofthe second cap 316 has a first portion 392, a second portion 394, athird portion 396, and a fourth portion 398. The first portion 392extends from the first end 384 toward the second end 386 and has a firstinside diameter 391. The second portion 394 extends from the firstportion 392 to the third portion 396 and has a second inside diameter393 that tapers from the first portion 392 to the third portion 396. Thethird portion 396 extends from the second portion 394 to the fourthportion 398 and has an inside diameter 395 that tapers from the secondportion 394 to the fourth portion 398. The fourth portion 398 extendsfrom the third portion 396 to the second end 386 and has an insidediameter 397 that is sized and configured to allow fluid to pass throughthe passageway 390 to the second one-way valve 412, as described in moredetail herein.

In the illustrated embodiment, the first cap 314 has a first end 420, asecond end 422, and a main body 424 that defines a passageway 426 and arecess 428. The passageway 426 extends from the first end 420 to therecess 428 and is sized and configured to allow fluid to pass throughthe passageway 426. The first one-way valve 410 is releasably attachedto the first end 420 of the first cap 314 and the second one-way valve412 is releasably attached to the second end 386 of the second cap 316.Each of the first and second one-way valves 410, 412 has a first opening430, a second opening 432, and is adapted to allow fluid to pass throughthe valve in one direction. In the illustrated embodiment, the firstone-way valve 410 is adapted to allow fluid to pass through the valvefrom the first opening 430 to the second opening 432 and the secondone-way valve 412 is adapted to allow fluid to pass through the valvefrom the second opening 432 to the first opening 430. Alternatively, afirst one-way valve can be adapted to allow fluid to pass through thevalve from a first opening to a second opening, or from a second openingto a fist opening, and/or a second one-way valve can be adapted to allowfluid to pass through the valve from a first opening to a secondopening, or from a second opening to a first opening. In alternativeembodiments, a first one-way valve and/or second one-way valve can beomitted from a storage device and/or loading device, as described inmore detail herein, and a first cap can define a recess and omit theinclusion of a passageway, a second cap can define a recess and omit theinclusion of a passageway, and/or a loading member can define a recessand omit the inclusion of a passageway. Alternatively, a first one-wayvalve and/or second one-way valve can be omitted from a storage deviceand/or loading device, as described in more detail herein, and a cap canbe disposed on a first end of a first cap, a second end of a second cap,and/or a second end of a loading member to seal the passageway definedby the first cap, the passageway defined by the second cap, and/or thepassageway defined by the loading member such that fluid cannot passthrough the passageway(s). Alternatively, a first one-way valve and/orsecond one-way valve can be omitted from a storage device and/or loadingdevice, as described in more detail herein, and a first two-way valveand/or second two-way valve can be included in the storage device and/orloading device in place of any one-way valves. Alternatively, a firstone-way valve and/or second one-way valve included in a storage devicecan be permanently fixed to a cap, disposed within a recess defined by acap, or other component, of the storage device.

The diffuser 414 is releasably disposed within the first portion 338 ofthe passageway 332 and the through hole 342 of the separating wall 334.As shown in FIGS. 13 and 14, the diffuser 414 has a first end 434, asecond end 436, a base 438, and a frame 440. The base 438 extends fromthe second end 436 toward the first end 434 to the frame 440 and issized and configured to be received by the through hole 342 of theseparating wall 334. The base 438 has an outside diameter 439 that isequal to the inside diameter 345 of the through hole 342 (e.g., suchthat the diffuser seals the through hole 342). Alternative embodiments,however, can include a diffuser that has a base with an outside diameterthat is less than, greater than, or about, an inside diameter of athrough hole. The storage member 312 and the diffuser 414 define matingstructure that achieves a snap-fit attachment between the base 438 ofthe diffuser 414 and the separating wall 334 of the storage member 312.The frame 440 extends from the base 438 to the first end 434 and has aplurality of struts 442 that define a plurality of openings 446 that aresized and configured to allow a fluid to pass through the frame 432during use. The diffuser 414 provides a mechanism for dispersing a fluidpassed through the storage member 312 during use such that the fluid canpass through the plurality of holes 336 and/or through the through hole342 in embodiments in which the base 438 of the diffuser 414 does notseal the through hole 342. In alternative embodiments, a diffuser can beomitted from a storage device and/or loading device, as described inmore detail herein.

While the diffuser 414 has been illustrated as having a particularstructural arrangement and as being releasably disposed within a firstportion of a storage member, a diffuser can have any suitable structuralarrangement and can be positioned within a storage member at anysuitable location. Selection of a suitable structural arrangement for adiffuser and of a suitable location to position a diffuser within astorage member can be based on various considerations, including thestructural arrangement of a storage member within which the diffuser isdisposed. Examples of suitable locations for positioning a diffuserwithin a storage member include such that a diffuser is releasablydisposed within a first portion of a storage device, releasably disposedwithin a second portion of a storage device, permanently, or releasably,attached to a cap (e.g., first cap, second cap) of a storage device,permanently, or releasably, attached to a storage member (e.g., within afirst portion of a passageway, within a second portion of a passageway),and any other location considered suitable for a particular embodiment.

The storage device 310 provides a mechanism for decreasing thecomplexity of sterilizing, storing, rinsing, and/or loading animplantable medical device and minimizing the risk associated withhandling an implantable medical device that is intended forimplantation. For example, the storage device 310 provides a mechanismfor sterilizing, storing, rinsing, and/or loading an implantable medicaldevice using a closed system that reduces the interaction with theimplantable medical device during sterilization, storing, rinsing,and/or loading.

FIGS. 15, 16, and 16A illustrate another example storage device 510. Thestorage device 510 is similar to the storage device 310 illustrated inFIGS. 8, 9, 10, 11, 12, 13, and 14 and described above, except asdetailed below. The storage device 510 includes a storage member 512, afirst cap 514, a second cap 516, a first one-way valve 610, a secondone-way valve 612, a diffuser 614, an implantable medical device 650,and a loading puller 652.

In the illustrated embodiment, the implantable member device 650comprises a frame 654 and a material 656 attached to the frame 654. Theimplantable medical device 650 is disposed within the second portion 540of the storage member 512 such that a fluid can pass over the outsideand inside surfaces of the implantable medical device 650 when the fluidis passed through the first portion 538 of the storage member 512 andinto the second portion 540 via the plurality of holes 536 and thethrough hole 542 of the separating wall 534.

In the illustrated embodiment, the loading puller 652 is releasablyattached to the implantable medical device 650 and is partially disposedwithin each of the storage member 512 and the second cap 516. Theloading puller 652 has a lengthwise axis 657, a first end 658, a secondend 660, a length 661, and main body 662 that defines a first bend 664,a second bend 666, a third bend 668, and a fourth bend 670. The loadingpuller 657 is sized and configured to mate with a notch defined by anelongate member of a delivery system, as described in more detailherein. The first bend 664 is positioned near the first end 658 betweenthe first end 658 and the second bend 666 and the fourth bend 670 ispositioned near the second end 660 between the second end 660 and thethird bend 668 such that the loading puller defines two hooked ends 672,674 that partially surround a portion of the frame 654 of theimplantable medical device 650 when the loading puller 652 is releasablyattached to the implantable medical device 650. The first hooked end 672is opposably positioned from the second hooked end 674 relative to alengthwise axis 657 of the loading puller 652. The second bend 666 isdisposed between the first bend 664 and the third bend 668 and the thirdbend 668 is disposed between the second bend 666 and the fourth bend 670such that the loading puller 652 defines a u-shaped member 676. Theloading puller 652 is moveable between a first, uncompressed, or open,configuration and a second, compressed, or closed, configuration. In theclosed configuration, the loading puller 652 has a width disposedbetween the hooked end 672, 674 that is less than the outside diameterof an implantable medical device such that the loading puller 652 can bereleasably attached to the implantable medical device. In the closedconfiguration, a portion of the loading puller 652 (e.g., hooked ends672, 674) is disposed within one or more openings 651 defined by a frameof an implantable medical device 650, such that the loading puller 652is capable of applying axial force on the implantable medical device 650when axial force is applied to the loading puller 652, as shown in FIG.16B. In the open configuration, the loading puller 652 has a widthdisposed between the hooked ends 672, 674 that is greater than theoutside diameter of the implantable medical device such that the loadingpuller is free of the implantable medical device. In the illustratedembodiment, the loading puller 652 is biased to the open configuration.

While the loading puller 652 has been illustrated as having a particularstructural arrangement, a loading puller can have any suitablestructural arrangement capable of providing releasable attachment to animplantable medical device and advancing the implantable medical devicethrough a storage device and/or loading device, as described in moredetail herein. Selection of a suitable structural arrangement for aloading puller can be based on various considerations, such as thestructural arrangement of an implantable medical device to which theloading puller is intended to be attached. For example, while loadingpuller 652 has been illustrated as having a first hooked end 672 that isopposably positioned from a second hooked end 674 relative to thelengthwise axis 657 of the loading puller 652, a first hooked end can bepositioned at any suitable location relative to a second hooked endrelative to a lengthwise axis of the loading puller. While the loadingpuller 652 has been illustrated as defining four bends, a loading pullercan define any suitable number of bends. Examples of numbers of bendsconsidered suitable for a loading puller to define include one, at leastone, two, a plurality, three, four, five, more than five, and any othernumber considered suitable for a particular embodiment. For example, aloading puller can define only first and second bends to define firstand second hooked ends and can include a curve defined between the firstbend and the second bend such that the first hooked end is opposablypositioned from the second hooked end. Alternatively, a loading pullercan define only first, second, and third bends to define first andsecond hooked ends and the third bend can be defined between the firstbend and the second bend such that the first hooked end is opposablypositioned from the second hooked end.

A loading puller 652 can be formed of any suitable material and usingany suitable method of manufacture and selection of a suitable materialand method of manufacture can be based on various considerations,including the material forming an implantable medical device to whichthe loading puller is intended to be releasably attached. Examples ofmaterials considered suitable to form a loading puller includebiocompatible materials, materials that can be made biocompatible,metals, shape memory alloys, Nitinol, plastics, and any other materialconsidered suitable for a particular embodiment. In the illustratedembodiment, the loading puller is formed of Nitinol.

FIG. 17 illustrates an example loading device 710. The loading device710 includes a loading member 712, a first cap 714, a second cap 716, animplantable medical device 718, and a loading puller 720. Theimplantable medical device 718 is similar to the implantable medicaldevice 650 illustrated in FIGS. 15 and 16 and described above, except asdetailed below. The loading puller 720 is similar to the loading puller652 illustrated in FIGS. 15 and 16 and described above, except asdetailed below.

In the illustrated embodiment, the loading member 712 has a lengthwiseaxis 721, a first end 722, a second end 724, and a main body 726 thatdefines a first opening 728, a second opening 730, and a passageway 732.The passageway 732 extends from the first opening 728 to the secondopening 730 and has a first portion 734, a second portion 736, a thirdportion 738, and a fourth portion 740. The passageway 732 is sized andconfigured to house the implantable medical device 718. The firstportion 734 extends from the first end 722 to the second portion 736 andhas an inside diameter 735. The second portion 736 extends from thefirst portion 734 to the third portion 738 and has an inside diameter737 that tapers from the first portion 734 to the third portion 738. Thethird portion 738 extends from the second portion 736 toward the secondend. In the illustrated embodiment, the third portion 738 extends fromthe second portion 736 to the second end 724, has a firstcross-sectional configuration taken along a plane orthogonal to thelengthwise axis 721 (e.g., circular cross-sectional configuration), andhas an inside diameter 739 that is less than the inside diameter 735 ofthe first portion 734. The fourth portion 740 extends from the thirdportion 738 (e.g., a location between the second end 724 and the secondportion 736) to the second end 724, has a second cross-sectionalconfiguration taken along a plane orthogonal to the lengthwise axis 721(e.g., elongated cross-sectional configuration, rectangularcross-sectional configuration), and has a width 741 (measured on a planethat is orthogonal to the lengthwise axis 721) that is greater than theinside diameter 739 of the third portion 738 and less than the insidediameter 735 of the first portion 734 of the passageway 732. In use,when the loading puller 720 is pulled through the passageway 732 theloading puller 720 is in its closed configuration and the implantablemedical device 718 is in its compressed configuration as its movesthrough the second portion 736 of the passageway 732. When the loadingpuller 720 reaches the fourth portion 740 of the passageway 732 itexpands to its open configuration while the implantable medical device718 remains in its compressed configuration. While the implantablemedical device 718 is illustrated as being disposed within the firstportion 734 of the passageway 732, an implantable medical device can bedisposed within any suitable portion of a loading member. Depending onthe structural arrangement of an implantable medical device intended tobe positioned within a loading device, a passageway can have anysuitable structural arrangement, For example, the various portions ofthe passageway can have any suitable cross-sectional configuration, suchas circular, elongated, oval, rectangular, a portion of a passageway canhave a constant inside diameter along the length of the portion, aninside diameter that varies along the length of the portion (e.g.,tapers from the first end toward the second end, or a location betweenthe first end and the second end toward the second end, defines ashoulder within the portion such that a first inside diameter is betweenthe first end and the shoulder and a second inside diameter is betweenthe shoulder and the second end that is greater than the first insidediameter), or any other arrangement considered suitable for a particularembodiment.

The second cap 716 is releasably attached to the second end 724 of theloading member 712 and has a first end 742, a second end, 744, and amain body 746 that defines a recess 748 and a recess base 750. Therecess 748 has a first portion 752 and a second portion 754. The firstportion 752 has a first inside diameter 753 and the second portion 754has a second inside diameter 755 that is less than the first insidediameter 753 of the first portion 752. The second portion 754 is sizedand configured to receive a portion of the loading puller 720. Thesecond cap 716 and the loading member 712 define mating structure thatachieves a snap-fit attachment between the second cap 716 and theloading member 712.

In the illustrated embodiment, the first cap 714 comprises a deviceguard 715 that is releasably attached to the first end 722 of theloading member 712 and partially extends into the passageway 732 definedby the loading member 712. The device guard 715 has a first end 756, asecond end 758, and a main body 760 that defines a base 762, a sidewall764, a projection 766, and a recess 768 that extends into the projection766. The base 762 and the sidewall 764 cooperatively define a cavity 770that is sized and configured to receive a portion of the loading member712. The projection 766 extends from the base 762, through the cavity770, and to an environment exterior to the cavity 770. The recess 768extends from the second end 758 toward the first end 756 to a recessbase 769. The recess 768 is sized and configured to receive a portion ofa delivery system, as described in more detail herein. While deviceguard 715 has been illustrated as being releasably attached to loadingmember 712, any suitable device guard, such as those described herein(e.g., device guard 146, device guard 1714), or cap, such as thosedescribed herein (e.g., cap 14), can be releasably attached to a loadingmember. Alternative embodiments can include a device guard that includesa projection that has a length that is greater than, or equal to, a tipof a delivery system or that defines an opening on a first end or ahollowed extension that is sized and configured to receive a portion ofa tip of a delivery system.

In the illustrated embodiment, the loading puller 720 is releasablyattached to the implantable medical device 718 and is partially disposedwithin each of the loading member 712 (e.g., passageway 732) and thesecond cap 716. In embodiments that include first and second tracks, asdescribed in more detail herein, a loading puller is partially disposedwithin the passageway defined by the loading member, a first track, anda second track.

Optionally, a loading device can include a port (e.g., port 121), afirst two-way valve (e.g., valve 123), a passageway defined on a firstcap (e.g., passageway 426), a passageway defined on a second cap (e.g.,passageway 125), and a second two-way valve (e.g., valve 127). In theseembodiments, an implantable medical device can be positioned within theloading member (e.g., first portion of passageway) and the caps can bepositioned on the loading member as described. Subsequently, if notalready sterilized, a sterilizing material can be passed through theloading member using the port to sterilize the implantable medicaldevice using the first and second two-way valves and any suitablecomponents attached to the valves to pass the sterilizing materialthrough the loading member. After sterilization, a rinsing material canbe passed through the loading member using the port to rinse theimplantable medical device using the first and second two-way valves andany suitable components attached to the valves to pass the rinsingmaterial through the loading member. Optionally, a holding material canbe passed through the loading member using the port to store theimplantable medical device using the first and second two-way valves andany suitable components attached to the valves to pass the holdingmaterial through the loading member. This structural arrangementprovides a mechanism for sterilizing, rinsing, and storing animplantable medical device such that the implantable medical device isnot contacted by any component until a delivery system, as describedherein, is used to deliver the implantable medical device.

The loading device 710 provides a mechanism for decreasing thecomplexity of sterilizing, storing, rinsing, and/or loading animplantable medical device and minimizing the risk associated withhandling an implantable medical device that is intended forimplantation. For example, the loading device 710 provides a mechanismfor sterilizing, storing, rinsing, and/or loading an implantable medicaldevice using a closed system that reduces the interaction with theimplantable medical device during sterilization, storing, rinsing,and/or loading.

FIGS. 18, 19, 20, 21, 22, 23, 24, 25, and 26 illustrate another exampleloading device 810. The loading device 810 includes a storage member812, a first cap 814, a first one-way valve 910, a second one-way valve912, a diffuser 914, a loading member 1012, a second cap 1014, aconnector 1016, and a loading puller 1020. Each of the storage member812, the first cap 814, the first one-way valve 910, the second one-wayvalve 912, and the diffuser 914 is similar respectively to the storagemember 312, the first cap 314, the first one-way valve 410, the secondone-way valve 412, and the diffuser 414 illustrated in FIGS. 8, 9, 10,11, 12, 13, and 14 and described above, except as detailed below. Eachof the loading member 1012 and the second cap 1014 is similarrespectively to the loading member 712 and cap 714 illustrated in FIG.17 and described above, except as detailed below.

As shown in FIGS. 19 and 24, the main body 824 of the storage member 812defines first and second posts 1074, 1076, protuberances 1078, and arecess 1079. Each of the first and second posts 1074, 1076 extends fromthe first end 820 and away from the second end 822 to an end 1073. Eachof the posts 1074, 1076 has a first outside diameter 1075 at the end1073 of the post and a second outside diameter 1077 between the end ofthe post and the first end 820 of the first cap 812. The second outsidediameter is less than the first outside diameter. Each protuberance 1078extends from the second end 822 and away from the first end 820 and issized and configured to be received by a recess 1098 defined by theloading member 1012, as shown in FIG. 21. The recess 1079 extends intothe main body 824 from an exterior surface and toward the lengthwiseaxis 813 of the storage member 812. The recess 1079 is sized andconfigured to receive a portion of the connector 1016, as described inmore detail herein.

As shown in FIGS. 19 and 25, the diffuser 914 is permanently attached tothe first cap 814, the first one-way valve 910 is permanently attachedto the first cap 814, and the first cap 814 defines first and secondopenings 1080, 1082 that are each sized and configured to receive aportion of a post 1074, 1076 defined by the storage member 812. Eachopening 1080, 1082 has a first portion 1084 sized and configured toreceive the portion of a post 1074, 1076 that has the first outsidediameter 1075 and a second portion 1086 that is sized and configured toreceive the portion of a post 1074, 1076 that has the second outsidediameter 1077. In use, the first cap 814 is positioned on the storagemember 812 such that the first post 1074 is disposed within the firstopening 1080 and the second post 1076 is disposed within the secondopening 1082. After the posts 1074, 1076 have been positioned within theopenings 1080, 1082, the first cap 814 is rotated relative to thestorage member 812 about the lengthwise axis 813 of the storage member812 to achieve releasable attachment between the storage member 812 andthe first cap 814.

In the illustrated embodiment, the loading member 1012 is releasablyattached to the storage member 812 using the connector 1016 and the mainbody 1026 of the loading member 1012 defines a plurality of recesses1088, a first track 1090, a second track 1092, first and second posts1094, 1096, a plurality of recesses 1098, and recess 1099. Each recessof the of the plurality of recesses 1088 extends from the first end 1022of the loading member 1012 toward the second end 1024 and terminates atthe junction between the first portion 1034 and the second portion 1036of the passageway 1032. Each recess of the plurality of recesses 1088has a first width 1087 at the first end 1022 of the loading member 1012and a second width 1089 between the first end 1022 and the second end1024. The first width 1087 is greater than the second width 1089 suchthat each recess of the plurality of recesses tapers from the first end1022 toward the second end 1024. Each of the first track 1090 and thesecond track 1092 extends from the first end 1022 of the loading member1012, into the main body 1026, through each of the first portion 1034,second portion 1036, and a portion of the third portion 1038 of thepassageway 1032, to the fourth portion 1040 of the passageway 1032 andis sized and configured to receive a portion of the loading puller 1020.Each of the first and second tracks 1090, 1092 provides a mechanism toguide the loading puller 1020 through the loading member 1012 duringuse. Each of the first and second posts 1094, 1096 extends from thesecond end 1024 of the loading member 1012 and away from the first end1022 to an end 1093. Each of the posts 1094, 1096 has a first outsidediameter 1095 at the end 1093 of the post and a second outside diameter1097 between the end 1093 of the post and the second end 1024 of theloading member 1012. The second outside diameter 1097 is less than thefirst outside diameter 1095. Each recess 1098 extends from the first end1022, into the main body 1026 of the loading member 1012, and is sizedand configured to receive a protuberance 1078 defined by the storagemember 812. When the protuberances 1078 are received within the recesses1098, the plurality of recesses 916 defined by the storage member 812 isaligned with the plurality of recesses 1088 defined by the loadingmember 1012. The recess 1099 extends into the main body 1026 from anexterior surface and toward the lengthwise axis 1021 of the loadingmember 1012. The recess 1099 is sized and configured to receive aportion of the connector 1016, as described in more detail herein.

While each recess of the plurality of recesses 1088 has been illustratedas extending from the first end 1022 of the loading member 1012 towardthe second end 1024 and terminating at the junction between the firstportion 1034 and the second portion 1036 of the passageway 1032 and ashaving a first width 1087 at the first end 1022 of the loading member1012 and a second width 1089 between the first end 1022 and the secondend 1024 that is less than the first width 1087, each recess can haveany suitable structural arrangement. Selection of a suitable structuralarrangement for each recess included in a loading member can be based onvarious considerations, including the structural arrangement of animplantable medical device intended to be passed through a loadingmember. For example, a loading member can define any suitable number ofrecesses, such as one, at least one, two, a plurality, three, four,five, more than five, more than ten, and any other number consideredsuitable for a particular embodiment. A recess included on a loadingmember can extend any suitable length of a loading member. For example,a recess, or each recess of a plurality of recesses, can extend from afirst end to a second end of a loading member, from a first end to alocation between the first end and the second end of a loading member,from a location between a first end and a second end to the second endof the loading member, from a first location between a first end and asecond end to a second location between the first location and thesecond end of a loading member, and any other length of a loading memberconsidered suitable for a particular embodiment. A recess included on aloading member can have any suitable width along its length. Forexample, a recess, or each recess of a plurality of recesses, can have afirst width at a first end (e.g., at a first end of a loading member)and a second width at a second end (e.g., between a first end and asecond end of a loading member) that is greater than, less than, equalto, or about the first width. A recess included on a loading member canhave any suitable structural arrangement, such as curved, cuboidal,prismatic, and any other structural arrangement considered suitable fora particular embodiment.

In the illustrated embodiment, the second cap 1014 is releasablyattached to the second end 1024 of the loading member 1012 and thesecond one-way valve 912 is permanently attached to the second end 1044of the second cap 1014. Alternative embodiment, however, can include acap that incorporates a one-way or two-way valve within the cap suchthat a separate component attached to the cap is not needed. The mainbody 1046 of the second cap 1014 defines a passageway 1102 that extendsthrough the second end 1044 and provides access to the recess 1048. Asshown in FIG. 23, the second cap 1014 defines first and second openings1104, 1106 that are each sized and configured to receive a portion of apost 1094, 1096 defined by the loading member 1012. Each opening 1104,1106 has a first portion 1108 sized and configured to receive theportion of a post 1094, 1096 that has the first outside diameter 1095and a second portion 1110 that is sized and configured to receive theportion of a post 1094, 1096 that has the second outside diameter 1097.In use, the second cap 1014 is positioned on the loading member 1012such that the first post 1094 is disposed within the first opening 1104and the second post 1096 is disposed within the second opening 1106.After the posts 1094, 1096 have been positioned within the openings1104, 1106, the second cap 1014 is rotated relative to the loadingmember 1012 about the lengthwise axis 1021 of the loading member 1012 toachieve releasable attachment between the loading member 1012 and thesecond cap 1014.

The connector 1016 is releasably attached to the storage member 812 andthe loading member 1012. The connector 1016 has a lengthwise axis 1113,a first end 1114, a second end 1116, and a main body 1118 that defines afirst projection 1120 and a second projection 1122. Each of the firstprojection 1120 and the second projection 1122 extends from the mainbody 1118 and toward the lengthwise axis 1113 of the connector 1016. Thefirst projection 1120 is sized and configured to be received by therecess 1079 defined by the storage member 812 and the second projection1122 is sized and configured to be received by the recess 1099 definedby the loading member 1012. The connector 1016 provides releasableattachment between the storage member 812 and the loading member 1012.In an alternative embodiment, a connector can be omitted and a storagemember can be directly attached to a loading member using any suitablemethod or technique that achieves releasable attachment, such as thosedescribed herein. Alternatively, a connector can be permanently attachedto a storage member and a loading member (e.g., using a crimpconnection).

Any of the storage devices and/or loading devices described herein canoptionally include an implantable medical device housed within a secondportion of a storage member. Any suitable implantable medical device canbe included in a storage member and selection of a suitable implantablemedical device can be based on various considerations, including thetreatment intended to be performed. Examples of implantable medicaldevices considered suitable to include in a storage member includeimplantable medical devices that include a frame, such as a supportframe, implantable medical devices that include a frame and a materialattached to the frame, venous valves, heart valves, stents, occludersthat include a frame along with leaflets that are sewn or otherwiseattached to each other to permanently close an associated valve orificeor a graft material that lacks an orifice, and any other implantablemedical device considered suitable for a particular embodiment.

Examples of frames considered suitable to include on an implantablemedical device include those that comprise an expandable frame havingradially compressed and radially expanded configurations. Such a framecan be implanted at a point of treatment within a body vessel byminimally invasive techniques, such as delivery and deployment with adelivery system, such as those described herein, that is sized andconfigured for navigation within the body vessel. It is noted, though,that implantable medical devices, such as frames, regardless of the typeand/or nature of the frame, can be implanted within a body vessel at adesired point of treatment using conventional minimally-invasivetechniques, such as by delivery with an associated delivery system, suchas those described herein, by surgical techniques, or by any othersuitable technique for placing a frame or medical device at a point oftreatment within a body vessel.

A frame can be self-expandable or can require an input of force toaffect expansion, such as a balloon expandable frame. A frame canprovide a stenting function, i.e., exert a radially outward force on theinterior wall of a vessel in which the frame, or implantable medicaldevice including the frame, is implanted. By including a frame thatexerts such a force, an implantable medical device can provide multiplefunctions, such as a stenting and a valving function, at a point oftreatment within a body vessel, which may be desirable in certainsituations, such as when a degree of vessel stenosis, occlusion, and/orweakening is present.

A frame of an implantable medical device can include any suitablestructural elements, such as struts and bends, conventional structuralfeatures that facilitate anchoring of the frame at a point of treatmentwithin a body vessel, such as barbs and/or microbarbs, and structuralfeatures, such as radiopaque markers, that facilitate visualization ofthe frame in conventional or other medical visualization techniques,such as radiography, fluoroscopy, and other techniques. Furthermore, aframe can include structural features, such as eyelets, barbs, filletsand other suitable structures, that provide attachment points for graftsand other materials.

A frame can be made from any suitable material and selection of anappropriate material for use in a frame according to a particularembodiment can be based on various considerations, including any desiredflexibility and visualization characteristics. The material selected fora frame need only be biocompatible or be able to be made biocompatible.Examples of suitable materials include, without limitation, stainlesssteel, nickel titanium (NiTi) alloys, e.g., Nitinol, other shape memoryand/or superelastic materials, molybdenum alloys, tantalum alloys,titanium alloys, precious metal alloys, nickel chromium alloys, cobaltchromium alloys, nickel cobalt chromium alloys, nickel cobalt chromiummolybdenum alloys, nickel titanium chromium alloys, linear elasticNitinol wires, polymeric materials, and composite materials. Absorbableand bioremodellable materials can also be used to form a frame. As usedherein, the term “absorbable” refers to the ability of a material todegrade and to be absorbed into a tissue and/or body fluid upon contactwith the tissue and/or body fluid. A number of absorbable materials areknown in the art, and any suitable absorbable material can be used.Examples of suitable types of absorbable materials include absorbablehomopolymers, copolymers, or blends of absorbable polymers. Specificexamples of suitable absorbable materials include poly-alpha hydroxyacids such as polylactic acid, polylactide, polyglycolic acid (PGA), orpolyglycolide; trimethlyene carbonate; polycaprolactone; poly-betahydroxy acids such as polyhydroxybutyrate or polyhydroxyvalerate; orother polymers such as polyphosphazines, polyorganophosphazines,polyanhydrides, polyesteramides, polyorthoesters, polyethylene oxide,polyester-ethers (e.g., polydioxanone) or polyamino acids (e.g.,poly-L-glutamic acid or poly-L-lysine). There are also a number ofnaturally derived absorbable polymers that may be suitable, includingmodified polysaccharides, such as cellulose, chitin, and dextran, andmodified proteins, such as fibrin and casein.

Stainless steel and nitinol are currently considered suitable materialsfor use in a frame of an implantable medical device due at least totheir biocompatibility, shapeability, and well-characterized nature.Also, cold drawn cobalt chromium alloys, such as ASTM F562 and ASTMF1058 (commercial examples of which include MP35N™ and Elgiloy™, both ofwhich are available from Fort Wayne Metals, Fort Wayne, Ind.; MP35N is aregistered trademark of SPS Technologies, Inc. (Jenkintown, Pa., USA);Elgiloy is a registered trademark of Combined Metals of Chicago LLC (ElkGrove Village, Ill., USA)), are currently considered suitable materialsfor frames at least because they are non-magnetic materials that providebeneficial magnetic resonance imaging (MRI) compatibility and avoid MRIartifacts typically associated with some other materials, such asstainless steel.

A frame can be fabricated in any suitable manner and by any suitabletechnique and selection of an appropriate manner and/or technique forfabricating a frame can be based on various considerations, includingthe nature of the material from which the frame is being fabricated.Examples of suitable techniques include forming a frame from wire, suchas by wrapping a suitable wire around a suitable mandrel, by cutting theframe from a tubular section of an appropriate material, such as bylaser-cutting the support frame from a metal tubular member, and byforming the desired structure of the frame in sheet form, such as byvapor deposition or other suitable technique, configuring the sheet intotubular form, such as by rolling or other suitable technique, and fixingthe frame in tubular form, such as by laser-welding or other suitabletechnique.

If an implantable medical device includes a frame and a materialattached to the frame, the material attached to the frame can form anysuitable structure and selection of a suitable structure for a materialattached to a frame to form can be based on various considerations,including the treatment intended to be performed. Any suitable materialcan be attached to the frame to form an implantable medical device andselection of an appropriate material for use with a frame in animplantable medical device can be based on various considerations,including the intended use and desired function of the implantablemedical device. For valve devices, such as venous valves, heart valves,or any other valve device, one or more leaflets, each having a freeedge, can be attached to a frame and comprise a section of material,such as a sheet, that is attached to the frame along a respectiveattachment pathway. The leaflets can be formed of any suitable material,and need only be biocompatible or be able to be made biocompatible. Thematerial can be formed of a flexible material. Examples of suitablematerials for use as leaflets in implantable medical devices includenatural materials, synthetic materials, and combinations of natural andsynthetic materials. Examples of suitable natural materials includeextracellular matrix (ECM) materials, such as small intestine submucosa(SIS), and other bioremodelable materials, such as bovine pericardium.Other examples of suitable ECM materials that can be used includestomach submucosa, liver basement membrane, urinary bladder submucosa,tissue mucosa, and dura mater. Other examples of suitable naturalmaterials include renal capsule matrix, abdominal fascia, parenchyma,such as abdominal parenchyma, connective tissue, pulmonary or lungligament, tissue laminates, and natural valve leaflets with or withoutadjacent vessel wall. Pleura is also considered a suitable naturalmaterial, including visceral pleura. Fixed tissues are also consideredsuitable, including fixed SIS, fixed pericardium, fixed pulmonary orlung ligament, and any other suitable fixed natural tissue. When fixedtissue is used, any suitable fixation technique and/or procedure can beused, including chemical fixatives, such as aldehydes, e.g.,formaldehyde, glutaraldehyde, and formalin, and carbodiimides, such asethyl dimethylaminopropyl carbodiimide, dicyclohexylcarbodiimide.Physical fixation techniques and/or procedures can also be used,including exposure to heat and/or radiation. Lyophilized preparationsand chemically-dried preparations of these natural materials are alsoconsidered suitable. Examples of suitable synthetic materials includepolymeric materials, such as expanded polytetrafluoroethylene,polyurethane, polyurethane urea, polycarbonate, and polyesters.

Any materials attached to a frame can have any suitable size, shape andconfiguration. For example, valve devices can include one, two or moreleaflets that are sheet-like sections of material attached to a frame.Another example of a material that can be attached to a frame is atubular structure that is attached around the outer circumference of theframe. Indeed, a tubular structure and one, two or more leaflets can beattached to a frame to form a valve device having an outer sleeve.

Any material and/or elements attached to a frame can be attached to theframe in any suitable manner and with any suitable structure and/orsubstance. For example, leaflets can be attached to a frame in a valvedevice using sutures, tissue welding, adhesive(s), mechanicalattachment(s), a combination of these approaches, and any other suitablestructure and/or substance.

The loading device 810 provides a mechanism for decreasing thecomplexity of sterilizing, storing, rinsing, and/or loading animplantable medical device and minimizing the risk associated withhandling an implantable medical device that is intended forimplantation. For example, the loading device 810 provides a mechanismfor sterilizing, storing, rinsing, and/or loading an implantable medicaldevice using a closed system that reduces the interaction with theimplantable medical device during sterilization, storing, rinsing,and/or loading.

FIGS. 27 and 28 illustrate an example delivery system 1210. The deliverysystem 1210 includes a sheath 1212, an elongate member 1214, and a tip1216.

The sheath 1212 has a first end 1220, a second end 1222, a length 1223,and a main body 1224 that defines a lumen 1226 that extends through theentire length 1223 and is sized and configured to receive a portion ofthe elongate member 1214, a portion of the tip 1216, and a portion of animplantable medical device. The second end of a sheath can optionallyinclude a radiopaque material. The elongate member 1214 has a lengthwiseaxis 1229, a first end 1230, a second end 1232, and a main body 1234that defines an outer surface 1236, an inner surface 1238, a lumen 1240,and a notch 1242. In the illustrated embodiment, the elongate member1214 is formed of 304 stainless steel. The lumen 1240 extends throughthe entire length of the elongate member 1214 and is sized (e.g.,0.035″) and configured to receive a portion of a wire guide, or anothermedical device. The notch 1242 extends into the main body 1234 of theelongate member 1214 from the outer surface 1236 to the inner surface1238, toward the lengthwise axis 1229, and toward the second end 1232 ofthe elongate member 1214 at an angle 1243. In the illustratedembodiment, the angle 1243 is greater than zero degrees relative to thelengthwise axis 1229 of the elongate member 1214. A notch can be definedat any suitable angle such as angles equal to, less than, greater than,or about 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degreesrelative to the lengthwise axis of an elongate member. The notch 1242 issized and configured to receive and mate with a portion of a loadingpuller, as described in more detail herein. In the illustratedembodiment, the angle 1243 is equal to about 45 degrees relative to thelengthwise axis 1229 of the elongate member 1214. While the elongatemember 1214 has been illustrated as defining an inner surface 1238 and alumen 1240, an alternative embodiment can include an elongate memberthat comprises a solid piece of material that does not include an innersurface that defines a lumen. In this alternative embodiment, a notchcan be defined in the main body the elongate member as described abovewith respect to elongate member 1214.

The tip 1216 is disposed on the second end 1232 of the elongate member1214 and has a first end 1246, a second end 1248, and a main body 1250that defines a lumen 1251, a first portion 1252, a second portion 1254,and a third portion 1256. The tip 1216 is sized and configured to bepartially disposed within the sheath 1212 and to receive an implantablemedical device thereon such that the implantable medical device can bedelivered to a point of treatment. In the illustrated embodiment, thefirst portion 1252 is sized and configured to be disposed within thesheath 1212. In an alternative embodiment, an elongate member can bedisposed through the lumen defined by a tip such that the tip isdisposed on a portion of the length of the elongate member. The notch1242 is positioned from the first end 1246 of the tip 1216 a distance1257 that is greater than the length of a loading puller such that theloading puller can be disposed within the notch and releasably attachedto an implantable medical device that is disposed between the notch 1242and the tip 1216 or disposed on the tip 1216. While the tip 1216 hasbeen illustrated as defining a lumen 1251, an alternative embodiment caninclude a tip that comprises a solid piece of material that omits alumen.

FIG. 29 illustrates another example delivery system 1310. The deliverysystem 1310 is similar to the delivery system 1210 illustrated in FIGS.27 and 28 and described above, except as detailed below. The deliverysystem 1310 includes a sheath 1312, an elongate member 1314, a tip 1316,and a gripping member 1360.

In the illustrated embodiment, the elongate member 1314 has a lengthwiseaxis 1329, a first end 1330, a second end 1332, and a main body 1334that defines an outer surface 1336. The gripping member 1360 is attachedto the elongate member 1314 between the first end 1330 of the elongatemember 1314 and the first end 1346 of the tip 1316. The gripping member1360 has a first end 1362, a second end 1364, a length 1365, and a mainbody 1366. In use, the gripping member 1360 is sized and configured tobe disposed within the lumen 1326 defined by the sheath 1312 and withina lumen defined by an implantable medical device disposed within astorage member. The gripping member 1360 provides a friction forcebetween the frame of an implantable medical device and the sheath 1312and assists with a controlled release of the implantable medical deviceduring delivery such that jumping of the implantable medical device isprevented when being released from the sheath 1312. In embodiments inwhich a balloon is included on a delivery system, the balloon can bepositioned between a tip and a gripping member, or be considered the tipand positioned distal to a gripping member. In these embodiments, theelongate member can define an inflation lumen that is in fluidcommunication with a balloon chamber and extends to an inflation portdefined distal to a sheath.

A gripping member can be formed of any suitable material and have anysuitable structural arrangement and selection of a suitable material andstructural arrangement for a gripping member can be based on variousconsiderations, including the intended use of a delivery system of whichthe gripping member is included. Examples of materials consideredsuitable for a gripping member include any material that has acoefficient of friction greater than the coefficient of friction of amaterial that forms an elongate member to which the gripping member isattached, polymers, silicone, polyurethane, rubbers, and any othermaterial considered suitable for a particular embodiment.

FIG. 30 illustrates another example delivery system 1410. The deliverysystem 1410 is similar to the delivery system 1210 illustrated in FIGS.27 and 28 and described above, except as detailed below. The deliverysystem 1410 includes a sheath 1412, an elongate member 1414, a tip 1416,and a gripping member 1460.

In the illustrated embodiment, the delivery system includes a grippingmember 1460 that is attached to the elongate member 1414 between thenotch 1442 and the first end 1446 of the tip 1416. The gripping member1460 has a first end 1462, a second end 1464, a length 1465, and a mainbody 1466. In use, the gripping member 1460 is sized and configured tobe disposed within the lumen 1426 defined by the sheath 1412 and withina lumen defined by an implantable medical device disposed within astorage member. In the illustrated embodiment, the gripping member 1460is positioned from the notch 1442 a distance that is greater than thelength of a loading puller intended to be used with the delivery system1410 (e.g., length 661, length 2761). Optionally, a delivery system caninclude an inner pusher catheter disposed within a sheath and over anelongate member that can be used to assist with delivery of animplantable medical device. In addition, a delivery system can includeone or more kerfs disposed between a notch and a proximal end of anelongate member.

FIGS. 31 and 32 illustrate an alternative tip 1516 that can be disposedthe second end of an elongate member of an example delivery system. Thetip 1516 is similar to the tip 1216 illustrated in FIG. 27 and describedabove, except as detailed below.

In the illustrated embodiment, the main body 1550 of the tip 1516defines shoulder 1570 and a planar surface 1572. The shoulder 1570 isdisposed between the first end 1546 of the tip 1516 and the second end1548 of the tip 1516. The planar surface 1572 extends from the shoulder1570 toward the second end 1548 to a location between the shoulder 1570and the second end 1548. The inclusion of a shoulder 1570 and a planarsurface 1572 provides a mechanism for orienting the tip 1516 and anattached elongate member relative to another component (e.g., loadingmember, storage member, device guard, planar surface of device guard),such as those described herein.

FIGS. 32A and 32B illustrate an alternative tip 1516′ that can bedisposed the second end of an elongate member of an example deliverysystem. The tip 1516′ is similar to the tip 1216 illustrated in FIG. 27and described above, except as detailed below.

In the illustrated embodiment, the main body 1550′ of the tip 1516′defines a first recess 1570′ and a second recess 1572′. Each of thefirst recess 1570′ and the second recess 1572′ extends from the firstend 1546′ toward the second end 1548′ and is sized and configured toreceive a portion of a device guard or cap such that the tip 1516′ andan attached elongate member can be oriented relative to anothercomponent (e.g., loading member, storage member, device guard, planarsurface of device guard), such as those described herein. In theillustrated embodiment, each of the first recess 1570′ and the secondrecess 1572′ is disposed on a plane that extends through the lengthwiseaxis of the tip 1516′. However, alternative embodiments can include afirst recess that is disposed on a first plane that extends through alengthwise axis of a tip and a second recess that is disposed on asecond plane that extends through the lengthwise axis of the tip at anysuitable angle relative to the first plane (e.g., 45 degrees).

While a first recess 1570′ and a second recess 1572′ have beenillustrated, a main body of a tip can define any suitable number ofrecesses to assist with orienting the tip relative to a portion of astorage device and/or loading device and selection of a suitable numberof recesses for a main body of a tip to define can be based on variousconsiderations, such as the type of material forming a tip. Examples ofsuitable numbers of recesses for a main body of a tip to define includeone, two, a plurality, three, four, five, more than five, and any othernumber considered suitable for a particular embodiment.

FIGS. 32C and 32D illustrate an alternative first cap 114′ that can bereleasably attached to a storage member of an example storage device orloading member of an example loading device. The first cap 114′ issimilar to the first cap 114 illustrated in FIGS. 4 and 5 and describedabove, except as detailed below.

In the illustrated embodiment, the first cap 114′ comprises a deviceguard 146′ that can be releasably attached to a first end of a storagemember or a loading member. The device guard 146′ has a lengthwise axis147′, a first end 148′, a second end 150′, and a main body 152′ thatdefines a base 154′, a first projection 156′, a recess 160′, a firstprojection 161′, and a second projection 163′. The base 154′ extendsfrom the first end 148′ toward the second end 150′ and is sized andconfigured to be releasably attached within a passageway of a storagemember. In the illustrated embodiment, the base 154′ has an outsidediameter 155′, a first side 162′, a second side 164′, and is sized andconfigured to be releasably attached to a storage member within apassageway using a snap fit attachment between the device guard 146′ andthe storage member.

The first projection 156′ extends from the second side 164′ to thesecond end 150′. The first projection 156′ has an outside diameter 157′that tapers from between the base 154′ and the second end 150′. Therecess 160′ extends from the first end 148′ toward the second end 150′to a recess base 166′ and is sized and configured to receive a portionof a delivery system (e.g., tip 1516′), as described in more detailherein. The recess 160′ has a first portion 168′ and a second portion170′. The first portion 168′ has an inside diameter 167′ that isconstant from the first end 148′ to the second portion 170′. The secondportion 170′ has an inside diameter 169′ that tapers from the firstportion 168′ to the recess base 166′. The first portion 168′ has acylindrical configuration and the second portion 170′ has a conicalconfiguration. Each of the first projection 161′ and the secondprojection 163′ extends into the recess 160′ and is sized and configuredto mate with and be disposed within a recess defined by a tip (e.g.,recess 1570′, recess 1572′) such that the delivery system isrotationally fixed relative to the device guard 146′ when theprojections 161′, 163′ are disposed within the recesses defined by thetip of the delivery system.

While a first projection 161′ and a second projection 163′ have beenillustrated, a main body of a device guard can define any suitablenumber of projections to assist with orienting a tip relative to aportion of a storage device and/or loading device and selection of asuitable number of projections for a main body of a device guard todefine can be based on various considerations, such as the type ofmaterial forming a tip. Examples of suitable numbers of projections fora main body of a device guard to define include one, two, a plurality,three, four, five, more than five, and any other number consideredsuitable for a particular embodiment.

FIGS. 33, 34, 35, and 36 illustrate an example guide system 1610. Theguide system 1610 includes a guide board 1612, a loading member 1614,and a guide member 1616. The loading member 1614 is similar to theloading member 712 illustrated in FIG. 17 and described above, except asdetailed below. The guide system 1610 can be used with any suitablestorage device described herein, such as storage device 10, storagedevice 110, storage device 210, storage device 310, and/or storagedevice 510.

The guide board 1612 has a first end 1620, a second end 1622, a firstside 1624, a second side 1626, a top surface 1628, a bottom surface1630, and a main body 1632 that defines a notch 1634 and a plurality ofapertures 1636. The notch 1634 extends from the first end 1620 to thesecond end 1622 and is sized and configured to receive the loadingmember 1614, the guide member 1616, and a storage member or a storagemember that includes an attached device guard, as described herein. Afirst set of apertures 1638 of the plurality of apertures 1636 isdisposed near the first end 1620 and a second set of apertures 1640 ofthe plurality of apertures 1636 is disposed between the first set ofapertures 1638 and the second end 1622.

In the illustrated embodiment, the loading member 1614 is disposedwithin the notch 1634 and is releasably attachable to the guide board1612 using mounting pins (not shown). The loading member 1614 has afirst portion 1615 releasably attached to a second portion 1617 usingthe mounting pins. Alternatively, a first portion and a second portionof a loading member can be positioned relative to one another and not bereleasably attached to one another. The loading member 1614 has alengthwise axis 1644, a first end 1646, a second end 1648, and a mainbody 1650 that defines a first opening 1652, a second opening 1654, apassageway 1656, a first track 1658, a second track 1660, a third track1662, a fourth track 1677, a plurality of mounting passageways 1663, andguide pins 1665. Each of the first opening 1652, the second opening1654, the passageway 1656, the first track 1658, the second track 1660,and the plurality of mounting passageways 1663 is cooperatively definedby the first and second portions 1615, 1617. The passageway 1656 extendsfrom the first opening 1652 to the second opening 1654 and has a firstportion 1664, a second portion 1666, a third portion 1668, a fourthportion 1670, and a fifth portion 1672. The passageway 1656 is sized andconfigured to receive an implantable medical device, a loading puller,and a portion of a delivery system, such as those described herein. Thefirst portion 1664 extends from the first end 1646 to the second portionand has a constant inside diameter. Alternative embodiments, however,could omit the inclusion of a first portion (e.g., first portion 1664).The second portion 1666 extends from the first portion 1664 to the thirdportion 1668 and has an inside diameter 1667 that tapers from the firstportion 1664 to the third portion 1668. The third portion 1668 extendsfrom the second portion 1666 to the fifth portion 1672 and has an insidediameter 1669 that is less than the inside diameter 1667 of the firstportion 1664 at the first end 1646. The third portion 1668 is sized andconfigured to receive a portion of an implantable medical device, aloading puller, and a portion of a delivery system (e.g., grippingmember). The fourth portion 1670 extends from the third portion 1668 tothe second end 1648 and has a width 1671 that is greater than the insidediameter 1669 of the third portion 1668. The fourth portion 1670 issized and configured to receive a portion of a loading puller in theopen, or partially opened, configuration, as described in more detailherein. The fifth portion 1672 extends from the third portion 1668(e.g., a location between the second end 1648 and the third portion1668) to the second end 1648 and has an inside diameter 1673 that isless than the width 1671 of the fourth portion 1670 and greater than theinside diameter 1669 of the third portion 1668. The fifth portion 1672is sized and configured to receive a portion of a sheath of a deliverysystem, as described in more detail herein. The decrease in diameterbetween the fifth portion 1672 and the third portion 1668 creates ashoulder 1674 that acts as a mechanical stop to advancement of a sheathof delivery system through the passageway 1656. In the illustratedembodiment, the third portion 1668 has a first cross-sectionalconfiguration taken along a plane orthogonal to the lengthwise axis 1644(e.g., circular cross-sectional configuration), the fourth portion 1670extends from the third portion 1668 (e.g., a location between the secondend 1648 and the second portion 1666) to the second end 1648 and has asecond cross-sectional configuration taken along a plane orthogonal tothe lengthwise axis 1644 (e.g., elongated cross-sectional configuration,rectangular cross-sectional configuration), and the fifth portion 1672has a third cross-sectional configuration taken along a plane orthogonalto the lengthwise axis 1644 (e.g., circular cross-sectionalconfiguration). In the illustrated embodiment, the first and thirdcross-sectional configurations are the same and are circular and thesecond cross-sectional configuration is different than the first andthird cross-sectional configurations and is elongated.

In use, when a loading puller is pulled through the passageway 1656 theloading puller is compressed as its moves through the second portion1666 of the passageway 1656 and then expands when it reaches the fourthportion 1670 of the passageway 1656.

Each of the first track 1658 and the third track 1662 is disposed on aplane that contains the lengthwise axis 1644 of the loading member,extends into the main body 1650 to a base 1651, and extends from thefirst end 1646 to the fourth portion 1670. However, alternativeembodiments can define a first track and a second track such that eachof the first and second tracks are disposed on a plane that does notcontain, or contact, the lengthwise axis of the loading member, or suchthat only one of the first and second tracks is disposed on a plane thatcontains, or contacts the lengthwise axis of the loading member. Each ofthe first track 1658 and the third track 1662 has a thickness measuredon a place orthogonal to the lengthwise axis 1644 when the first andsecond portions 1615, 1617 of the loading member 1614 are attached toone another. The distance between the base 1651 of the first track 1658and the base 1651 of the third track 1662 along the first portion 1664of the passageway 1656 is greater than the inside diameter of the firstportion 1664. The distance between the base 1651 of the first track 1658and the base 1651 of the third track 1662 along the second portion 1666of the passageway 1656 is greater than the inside diameter 1667 of thesecond portion 1666. The distance between the base 1651 of the firsttrack 1658 and the base 1651 of the third track 1662 along the thirdportion 1668 of the passageway 1656 is greater than the inside diameter1669 of the third portion 1668 and less than the width 1674 of thefourth portion 1670. Each of the second track 1660 and fourth track 1677extends from the first end 1646 to the fifth portion 1672. Inalternative embodiments, a second track and a fourth track can beomitted from a loading member. Each of the first track 1658 and thirdtrack 1662 is sized and configured to receive a portion of a loadingpuller and provides a mechanism to guide the loading puller through theloading member 1614 during use. Each of the second track 1660 and fourthtrack 1677 is sized and configured to receive a portion of animplantable medical device. For example, in embodiments in which theimplantable medical device includes a frame that has a portion thatextends outwardly from the lengthwise axis of the frame (e.g., one ormore markers, one or more barbs), one of, or each of, the second trackand fourth track provides a mechanism to guide the implantable medicaldevice through the loading member 1614 during use.

Each passageway of the plurality of mounting passageways 1663 is sizedand configured to align with the second set of apertures 1640 of theguide board 1612 such that one or more alignment pins (not shown) can bepositioned within the passageways and apertures to maintain the positionof the loading member 1614 relative to the guide board 1612. Each of theguide pins 1665 extends from the first end 1646 of the first portion1615 of the loading member 1614, away from the second end 1648, and issized and configured to be received by a passageway (e.g., passageway280, passageway 282) defined by a storage member to achieve alignmentbetween the storage member and the loading member 1614.

The guide member 1616 is disposed within the notch 1634 and isreleasably attachable to the guide board 1612 using mounting pins (notshown). The guide member 1616 has a first portion 1619 releasablyattached to a second portion 1621 using the mounting pins. The guidemember 1616 has a lengthwise axis 1675, a first end 1676, a second end1678, and a main body 1680 that defines a first opening 1682, a secondopening 1684, a passageway 1686, and a plurality of mounting passageways1688. Each of the first opening 1682, the second opening 1684, thepassageway 1686, and the plurality of mounting passageways 1688 iscooperatively defined by the first and second portions 1619, 1621. Thepassageway 1686 extends from the first opening 1682 to the secondopening 1684 and is sized and configured to receive a portion of adelivery system (e.g., sheath), such as those described herein. Theguide member 1616 provides a mechanism to maintain the position of adelivery system while loading an implantable medical device, asdescribed in more detail herein. Each passageway of the plurality ofmounting passageways 1688 is sized and configured to align with thefirst set of apertures 1638 of the guide board 1612 such that one ormore mounting pins (not shown) can be positioned within the passagewaysand apertures to maintain the position of the guide member 1616 relativeto the guide board 1612. While the guide board 1612, loading member1614, and guide member 1616 have been illustrated as separate elements,a guide board can be an integrated component with a loading memberand/or a guide member. For example, a guide member can be permanentlyattached to a guide board.

FIG. 37 illustrates an example kit 1710 that includes a storage device1712 according to an embodiment; a device guard 1714 according to anembodiment; a delivery system 1716 according to an embodiment; a guidesystem 1718 according to an embodiment; instructions for use 1720; and astorage container 1722.

Any suitable storage device, device guard, delivery system, loadingmember, loading assister, loading puller, and guide system can beincluded in a kit and selection of a suitable storage device, deviceguard, delivery system, loading member, loading assister, loadingpuller, and guide system to include in a kit can be based on variousconsiderations, including the type of implantable medical deviceintended to be implanted using the kit. Examples of storage devicesconsidered suitable to include in a kit include storage device 10,storage device 110, storage device 210, storage device 310, storagedevice 510, variations of the storage devices described herein, and anyother storage device according to an embodiment. Examples of deviceguards considered suitable to include in a kit include device guard 146,device guard 715, device guard 1714, device guard 2615, variations ofthe device guards described herein, and any other device guard accordingto an embodiment. Examples of delivery systems considered suitable toinclude in a kit include delivery system 1210, delivery system 1310,delivery system 1410, delivery system 2510, variations of the deliverysystems described herein, and any other delivery system according to anembodiment. Examples of loading members considered suitable to includein a kit include loading member 712, loading member 1012, loading member1614, loading member 2814, variations of the loading members describedherein, and any other loading member according to an embodiment.Examples of loading assisters considered suitable to include in a kitinclude loading assister 2710, and any other loading assister consideredsuitable for a particular embodiment. Examples of loading pullersconsidered suitable to include in a kit include loading puller 652,loading puller 2752, and any other loading puller considered suitablefor a particular embodiment. Examples of guide systems consideredsuitable to include in a kit include guide system 1610, variations ofthe guide systems described herein, and any other guide system accordingto an embodiment. In the illustrated embodiment, the kit 1710 includesstorage device 510, as shown in FIGS. 15, 16, and 16A, delivery system1410, as shown in FIG. 30, and guide system 1610, as shown in FIGS. 33,34, 35, and 36.

In the illustrated embodiment, the device guard 1714 is similar to thedevice guard 715 illustrated in FIG. 17 and described above, except asdetailed below. The device guard 1714 is releasably attachable to thefirst end 520 of the storage member 512 and the main body 1760 of thedevice guard 1714 defines a base 1762, a sidewall 1764, a projection1766, a first opening 1768, a second opening 1770, and a passageway1772. The base 1762 and the sidewall 1764 cooperatively define a cavity1770 that is sized and configured to receive a portion of the storagemember 512. The projection 1766 extends from the base 1762, through thecavity 1770, and to an environment exterior to the cavity 1770. Thepassageway 1772 extends from the first opening 1768 to the secondopening 1770 and is sized and configured to receive a portion of adelivery system, as described in more detail herein.

While the kit 1710 has been illustrated as including a single a storagedevice 510, a single device guard 1714, a single delivery system 1310,and a single guide system 1610, any suitable number, and type, ofstorage devices, device guards, delivery systems, loading members,loading pullers, loading assisters, and/or guide systems can be includedin a kit, such as those described herein. Selection of a suitable numberof storage devices, device guards, delivery systems, loading members,loading pullers, loading assisters, and/or guide systems to include in akit according to a particular embodiment can be based on variousconsiderations, such as the type of implantable medical device intendedto be implanted using the kit. Examples of suitable numbers of storagedevices, device guards, delivery systems, loading members, loadingpullers, loading assisters, and/or guide systems to include in a kitinclude at least one, one, two, a plurality, three, four and any othernumber considered suitable for a particular embodiment.

While the kit 1710 has been illustrated as including only a storagedevice 1712, a device guard 1714, a delivery system 1716, a guide system1718, instructions for use 1720, and a storage container 1720, a kit caninclude any suitable number of optional components. Examples of numbersof optional components considered suitable to include in a kit, such asan implantable medical device (e.g., disposed within a storage device,provided free of a storage device, pre-attached to a loading puller,pre-attached to a loading puller and disposed within a container,pre-attached to a loading puller and disposed within a loading member),include one, at least one, two, a plurality, three, four, five, morethan five, and any other number considered suitable for a particularembodiment. Examples of optional components and/or devices consideredsuitable to include in a kit include containers, or bags (e.g., I.V.bag) filled with saline, lubricant, a rinsing solution, or a flushingsolution, tubing, bowls, guide wires, catheters, syringes, and/or anyother component and/or device considered suitable for a particularembodiment.

A storage container included in a kit can have any suitable structuralarrangement and be formed of any suitable material and selection of asuitable structural arrangement and material to form a storage containercan be based on various considerations, including the number of storagedevices, device guards, delivery systems, loading members, and/or guidesystems included in a kit. Examples of structural arrangementsconsidered suitable to form a storage container include boxes, boxesthat include a lid, boxes that include a lid attached to the box (e.g.,pivotably attached), bags, and any other structural arrangementconsidered suitable for a particular embodiment. Examples of materialsconsidered suitable to form a storage container include metals,plastics, glass, combinations of the materials described herein, and anyother material considered suitable for a particular embodiment. In theillustrated embodiment, the storage container 1722 is a box 1723 formedof a rigid plastic.

FIG. 38 illustrates an example kit 1810 that includes a loading device1812 according to an embodiment; a device guard 1814 according to anembodiment; a delivery system 1816 according to an embodiment;instructions for use 1818; and a storage container 1820.

Any suitable loading device, device guard, and delivery system can beincluded in a kit and selection of a suitable loading device, deviceguard, and delivery system to include in a kit can be based on variousconsiderations, including the type of implantable medical deviceintended to be implanted using the kit. Examples of loading devicesconsidered suitable to include in a kit include loading device 710,loading device 810, variations of the loading devices described herein,and any other loading device according to an embodiment. Examples ofdevice guards considered suitable to include in a kit include deviceguard 146, device guard 715, device guard 1714, device guard 2615,variations of the device guards described herein, and any other deviceguard according to an embodiment. Examples of delivery systemsconsidered suitable to include in a kit include delivery system 1210,delivery system 1310, delivery system 1410, delivery system 2510,variations of the delivery systems described herein, and any otherdelivery system according to an embodiment. In the illustratedembodiment, the kit 1810 includes loading device 810, as shown in FIGS.18, 19, 20, 21, 22, 23, 24, 25, and 26, and delivery system 1410, asshown in FIG. 30.

While the kit 1810 has been illustrated as including a single a loadingdevice 1812, a single device guard 1814, and a single delivery system1816, any suitable number, and type, of loading devices, device guards,and/or delivery systems can be included in a kit, such as thosedescribed herein. Selection of a suitable number of loading devices,device guards, and/or delivery systems to include in a kit according toa particular embodiment can be based on various considerations, such asthe type of implantable medical device intended to be implanted usingthe kit. Examples of suitable numbers of loading devices, device guards,and/or delivery systems to include in a kit include at least one, one,two, a plurality, three, four and any other number considered suitablefor a particular embodiment.

While the kit 1810 has been illustrated as including only a loadingdevice 1812, a device guard 1814, a delivery system 1816, instructionsfor use 1818, and a storage container 1820, a kit can include anysuitable number of optional components. Examples of numbers of optionalcomponents considered suitable to include in a kit, such as animplantable medical device (e.g., disposed within a loading device,provided free of a loading device, pre-attached to a loading puller,pre-attached to a loading puller and disposed within a container,pre-attached to a loading puller and disposed within a loading member),include one, at least one, two, a plurality, three, four, five, morethan five, and any other number considered suitable for a particularembodiment. Examples of optional components and/or devices consideredsuitable to include in a kit include containers, or bags (e.g., I.V.bag) filled with saline, lubricant, a rinsing solution, or a flushingsolution, tubing, bowls, guide wires, catheters, syringes, and/or anyother component and/or device considered suitable for a particularembodiment.

A storage member, a cap, a device guard, a one-way valve, a two-wayvalve, a diffuser, a loading member, a loading puller, a loadingassister, a connector, a catheter, an elongate member, a pushing member,a tip, a guide board, a guide member, and any other device, component,element, or feature of the embodiments described herein can be formed ofany suitable material and using any suitable method of manufacture.Selection of a suitable material and method of manufacture can be basedon various considerations, including the intended use of the device,component, element, or feature. Examples of materials consideredsuitable to form a storage member, a cap, a device guard, a one-wayvalve, a two-way valve, a diffuser, a loading member, a loading puller,a loading assister, a connector, a catheter, an elongate member, apushing member, a tip, a guide board, a guide member, and any otherdevice, component, element, or feature of the embodiments describedherein include biocompatible materials, materials that can be madebiocompatible, metals, plastics, polymers, transparent materials, opaquematerials, and any other material considered suitable for a particularembodiment. Optionally, any of the storage member, a cap, a deviceguard, a one-way valve, a two-way valve, a diffuser, a loading member, aloading puller, a loading assister, a connector, a catheter, an elongatemember, a pushing member, a tip, a guide board, a guide member, and anyother device, component, element, or feature of the embodimentsdescribed herein can include a gasket (e.g., o-ring) disposed between itand another element to which it is attached.

Any attachment between a storage member, a cap, a device guard, aone-way valve, a diffuser, a loading member, a loading puller, a loadingassister, a connector, a catheter, an elongate member, a pushing member,a tip, a guide board, a guide member, and another element describedherein can utilize any suitable technique or method of attachmentbetween the elements. Selection of a suitable technique or method ofattachment between two elements can be based on various considerations,including the material(s) that forms the elements. Examples oftechniques and methods of attachment considered suitable between twoelements described herein include those illustrated, using threadedconnections, snap fit attachments, using one or more connectors, one ormore mating slots and projections, pierceable membranes between theelements, releasable attachments, permanent attachments, and any othertechnique or method of attachment considered suitable for a particularapplication.

Various methods sterilizing an implantable medical device, storing animplantable medical device, rinsing an implantable medical device, andloading an implantable medical device onto a delivery system aredescribed herein. While the methods described herein are shown anddescribed as a series of acts, it is to be understood and appreciatedthat the methods are not limited by the order of acts, as some acts mayin accordance with these methods, occur in the order shown and/ordescribed, in different orders, and/or concurrently with other actsdescribed herein.

FIG. 39 is a schematic illustration of an example method 1900 ofsterilizing an implantable medical device.

A step 1902 comprises inserting an implantable medical device into astorage member. Another step 1904 comprises attaching a first cap to thestorage member. Another step 1906 comprises introducing a sterilizingmaterial into the storage member. Another step 1908 comprisesintroducing a holding material into the storage member such that thesterilizing material is removed from the storage member. Another step1910 comprises attaching a second cap to the storage member.

Step 1902 can be accomplished using any suitable implantable medicaldevice, such as those described herein. In the illustrated embodiment,the example method of sterilizing an implantable medical device 1900comprises a method of sterilizing a valve device. Step 1902 can beaccomplished by applying an axial force on the implantable medicaldevice along the lengthwise axis of a storage member and directed towardan end (e.g., the first end, the second end) of the storage member untilthe implantable medical device is disposed within a portion of thepassageway defined by the storage member (e.g., first portion, secondportion). Any suitable storage member can be used to complete method1900, such as the storage members described herein. An optional stepthat can be completed prior to, or subsequent to, step 1902 comprisesreleasably attaching a loading puller to the implantable medical device.

Step 1904 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to either the first orsecond end of the storage member. Alternatively, step 1904 can compriseattaching a loading member to a storage member and can be accomplishedusing any suitable loading member, such as the loading members describedherein.

Step 1906 can be accomplished using any suitable method or technique ofintroducing a sterilizing material into storage member (e.g., using asyringe) and by passing the sterilizing material through the firstopening or second opening of the storage member such that it accumulateswithin the passageway defined by the storage member (e.g., within onlythe second portion of the passageway, within only the first portion ofthe passageway, within both the first portion and the second portion ofthe passageway), or passes through the passageway. Any suitablesterilizing material can be introduced into a storage member andselection of a suitable sterilizing material can be based on variousconsiderations, including the type of implantable medical devicedisposed within the storage member. Examples of sterilizing materialsinclude glutaraldehyde, formaldehyde, alcohol, and any other sterilizingmaterial considered suitable for a particular embodiment. An optionalstep comprises removing the sterilizing material from the storagemember. Optionally, step 1906 can be accomplished prior to step 1904.

Step 1908 can be accomplished using any suitable method or technique ofintroducing a holding material into storage member (e.g., using asyringe) and by passing the holding material through the first openingor second opening of the storage member such that it accumulates withinthe passageway defined by the storage member (e.g., within only thesecond portion of the passageway, only within the first portion of thepassageway, within both the first portion and the second portion of thepassageway), or passes through the passageway, and replaces anysterilizing material in the storage member. Any suitable holdingmaterial can be introduced into a storage member and selection of asuitable holding material can be based on various considerations,including the type of implantable medical device disposed within thestorage member. Examples of holding materials include glutaraldehyde,saline, formaldehyde, phosphate buffers, phosphate buffered saline(PBS), agents, biological agents, coatings, absorbable coatings, drugs,quenching solutions, quenching solutions that may include an amino acid,anti-calcification materials, rinsing fluids, flushing fluids, and anyother holding material considered suitable for a particular embodiment.Optionally, step 1908 can be completed multiple times (e.g., two times,three times). Optionally, step 1908 can be accomplished prior to step1904 and after step 1906.

Step 1910 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to the first or second endof a storage member that does not include a cap. In an alternativeembodiment, step 1904 can comprise attaching a cap to the storage memberand step 1910 can comprise attaching a loading member to a storagemember. FIG. 40 illustrates an implantable medical device 1912 storedwithin an example storage member 1914.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 1900, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 2000, example method 2100, examplemethod 2200, example method 2300, example method 2400, and/or examplemethod 2900.

FIG. 41 is a schematic illustration of another example method 2000 ofsterilizing an implantable medical device.

A step 2002 comprises inserting an implantable medical device into astorage member. Another step 2004 comprises attaching a first cap to thestorage member. Another step 2006 comprises attaching a second cap tothe storage member. Another step 2008 comprises introducing asterilizing material into the storage member. Another step 2010comprises introducing a holding material into the storage member suchthat the sterilizing material is removed from the storage member.

Step 2002 can be accomplished as described above with respect to step1902.

Step 2004 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to either the first orsecond end of the storage member. Alternatively, step 2004 can compriseattaching a loading member to a storage member and can be accomplishedusing any suitable loading member, such as the loading members describedherein.

Step 2006 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to the first or second endof a storage member that does not include a cap.

Step 2008 can be accomplished using any suitable method or technique ofintroducing a sterilizing material into storage member such that thesterilizing material is passed through the first opening or secondopening of the storage member and accumulates within the passagewaydefined by the storage member (e.g., within only the second portion ofthe passageway, within only the first portion of the passageway, withinboth the first portion and the second portion of the passageway), orpasses through the passageway. For example, a syringe or a lineconnected to a bag containing a sterilizing material can be attached toa first one-way valve and be utilized to introduce the sterilizing fluidinto the storage member such that the sterilizing material is containedwithin the storage member and does not pass through the second one-wayvalve. Alternatively, a syringe or a line connected to a bag can be usedto pass the sterilizing fluid through the second one-way valve and intothe storage member, or through the first one-way valve, the storagemember, and the second one-way valve, or through the second one-wayvalve, the storage member, and the first one-way valve. Any suitablesterilizing material can be introduced into a storage member, such asthose described herein. An optional step comprises removing the syringeor line from the one-way valve.

Step 2010 can be accomplished using any suitable method or technique ofintroducing a holding material into storage member such that the holdingmaterial is passed through the first opening or second opening of thestorage member and accumulates within the passageway defined by thestorage member (e.g., within only the second portion of the passageway,within only the first portion of the passageway, within both the firstportion and the second portion of the passageway), or passes through thepassageway. For example, a syringe or a line connected to a bagcontaining a holding material can be attached to a first one-way valveand be utilized to introduce the holding fluid into the storage membersuch that the holding material is contained within the storage memberand does not pass through the second one-way valve. Alternatively, asyringe or a line connected to a bag can be used to pass the holdingfluid through the second one-way valve and into the storage member, orthrough the first one-way valve, the storage member, and the secondone-way valve, or through the second one-way valve, the storage member,and the first one-way valve. An optional step comprises removing thesyringe or line from the one-way valve. Any suitable holding materialcan be introduced into a storage member, such as those described herein.Optionally, step 2010 can be completed multiple times (e.g., two times,three times). Each time step 2010 is completed, it can be completed fora particular period of time (e.g., 1 minute, 5 minutes) and/or until aspecified volume of holding fluid has been passed through storagemember. FIG. 42 illustrates an implantable medical device 2012 storedwithin an example storage member 2014 and a loading puller 2016 thatdefines only first and second bends and a curve between the first andsecond bends pre-attached to the implantable medical device 2012.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2000, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2100, examplemethod 2200, example method 2300, example method 2400, and/or examplemethod 2900.

FIG. 43 is a schematic illustration of an example method 2100 of storingan implantable medical device.

A step 2102 comprises inserting a sterilized implantable medical deviceinto a storage member. Another step 2104 comprises attaching a first capto the storage member. Another step 2106 comprises introducing a holdingmaterial into the storage member. Another step 2108 comprises attachinga second cap to the storage member.

Step 2102 can be accomplished as described above with respect to step1902. Optional steps that can be completed prior to step 2102 include:sterilizing the implantable medical device; rinsing the implantablemedical device; and/or attaching a loading puller to the implantablemedical device. These optional steps can be accomplished usingconventional sterilization and/or rinsing methods or those describedherein. In alternative embodiments, step 2102 can comprise obtaining asterilized implantable medical device disposed within a storage member.

Step 2104 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to either the first orsecond end of the storage member. Alternatively, step 2104 can compriseattaching a loading member to a storage member and can be accomplishedusing any suitable loading member, such as the loading members describedherein.

Step 2106 can be accomplished using any suitable method or technique ofintroducing a holding material into storage member (e.g., using asyringe) and by passing the holding material through the first openingor second opening of the storage member such that it accumulates withinthe passageway defined by the storage member (e.g., within only thesecond portion of the passageway, within only the first portion of thepassageway, within both the first portion and the second portion of thepassageway), or passes through the passageway. Any suitable holdingmaterial can be introduced into a storage member, such as thosedescribed herein. Optionally, step 2106 can be completed multiple times(e.g., two times, three times). Optionally, step 2106 can beaccomplished prior to step 2104 or subsequent to step 2108. Inembodiments in which step 2106 is accomplished subsequent to step 2108,step 2106 can be accomplished using any suitable method or technique ofintroducing a holding material into storage member such that the holdingmaterial is passed through the first opening or second opening of thestorage member and accumulates within the passageway defined by thestorage member (e.g., within only the second portion of the passageway,within only the first portion of the passageway, within both the firstportion and the second portion of the passageway), or passes through thepassageway. For example, a syringe containing a holding material can beattached to a first one-way valve and be utilized to introduce theholding fluid into the storage member such that the holding material iscontained within the storage member and does not pass through the secondone-way valve. Alternatively, a syringe can be used to pass the holdingfluid through the second one-way valve and into the storage member, orthrough the first one-way valve, the storage member, and the secondone-way valve, or through the second one-way valve, the storage member,and the first one-way valve. In this embodiment, step 2106 can becompleted multiple times (e.g., two times, three times). Each time step2106 is completed, it can be completed for a particular period of time(e.g., 1 minute, 5 minutes) and/or until a specified volume of holdingfluid has been passed through storage member. An optional step comprisesremoving the syringe or line from the one-way valve.

Step 2108 can be accomplished using any suitable cap, such as the capsdescribed herein, and the cap can be attached to the first or second endof a storage member that does not include a cap.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2100, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2000, examplemethod 2200, example method 2300, example method 2400, and/or examplemethod 2900.

FIG. 44 is a schematic illustration of an example method 2200 of rinsingan implantable medical device.

A step 2202 comprises attaching a device that includes a rinsingmaterial to a one-way valve of a storage device. Another step 2204comprises introducing the rinsing material into the storage device suchthat it passes through the storage device. Another step 2206 comprisesstopping the step of introducing the rinsing material into the storagedevice.

Step 2202 can be accomplished using any suitable method or technique ofattachment and using any suitable device that includes a rinsingmaterial, such as syringe, a line attached to a bag that includes arinsing material, and any other device considered suitable for aparticular embodiment. Any suitable rinsing material can be included ina device and selection of a suitable rinsing material can be based onvarious considerations, including the type of implantable medical devicedisposed within a storage member. Examples of rinsing materials includesaline, agents, biological agents, coatings, absorbable coatings, drugs,phosphate buffers, phosphate buffered saline (PBS), and any otherrinsing material considered suitable for a particular embodiment. In theembodiment described, a device is attached to a first one-way valve of astorage device. However, alternative embodiments can include a devicethat is attached to a second one-way valve, or a two-way valve, of astorage device.

While step 2202 has been described as being completed by attaching adevice to a storage device, an alternative embodiment can includeattaching a device to a loading device. Step 2202 can be accomplished byattaching the device to a first one-way valve of a storage device and/orloading device, a first two-way valve of a storage device and/or loadingdevice, a second one-way valve of a storage device and/or loadingdevice, or a second two-way valve of a storage device and/or loadingdevice.

Step 2204 can be accomplished using any suitable method or technique ofintroducing a rinsing material into storage device such that the rinsingmaterial is passed through the first opening or second opening of thestorage member and accumulates within the passageway defined by thestorage member (e.g., within only the second portion of the passageway,within only the first portion of the passageway, within both the firstportion and the second portion of the passageway), or passes through thepassageway. Alternatively, a syringe can be used to pass the rinsingfluid through the second one-way valve and into the storage member, orthrough the first one-way valve, the storage member, and the secondone-way valve, or through the second one-way valve, the storage member,and the first one-way valve. Alternatively, a syringe containing arinsing material can be attached to a first one-way valve and beutilized to introduce the rinsing fluid into the storage member suchthat the rinsing material is contained within the storage member anddoes not pass through the second one-way valve. Step 2204 can becompleted multiple times (e.g., two times, three times). Each time step2204 is completed, it can be completed for a particular period of time(e.g., 1 minute, 5 minutes) and/or until a specified volume of rinsingfluid has been passed through storage member.

Optionally, steps 2202, 2204, 2206 can be repeating one or more timesusing a second rinsing fluid that is different than the rinsing fluidinitially passed through the storage member. An optional step comprisesagitating the storage member during step 2204 or subsequent to thecompletion of step 2204.

While method 2200 has been described as being accomplished using aone-way valve, other embodiments can include a storage device and/orloading device that omits the inclusion of one or more one-way valves.In these embodiments, method 2200 can include the steps of: removing afirst cap, a second cap, a first one-way valve, and/or a second one-wayvalve; immersing the storage member in a rinsing material; optionallyagitating the storage member; and removing the storage member from therinsing material. In the methods described herein, any inclusion of aone-way valve can be substituted with a two-way valve in an alternativeembodiment.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2200, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2000, examplemethod 2100, example method 2300, example method 2400, and/or examplemethod 2900.

FIG. 45 is a schematic illustration of an example method 2300 of loadingan implantable medical device onto a delivery system.

A step 2302 comprises removing a first cap from a storage membercontaining an implantable medical device. Another step 2304 comprisesremoving a diffuser from the storage member. Another step 2306 comprisesattaching a device guard to the storage member. Another step 2308comprises removing a second cap from the storage member. Another step2310 comprises attaching the storage member to a loading member of aguide system. Another step 2312 comprises applying an axial force on aportion of a delivery system directed toward a storage member such thatit is passed through the storage member, the loading member, andpartially disposed within the device guard. Another step 2314 comprisespositioning a loading puller within a notch defined by an elongatemember of the delivery system. Another step 2316 comprises applying anaxial force on the elongate member of the delivery system directed awayfrom the storage member until the first and second ends of the loadingpuller are disposed within the fourth portion of the loading member.Another step 2318 comprises removing the loading puller from thedelivery system and loading member. Another step 2320 comprises applyingan axial force on a sheath of the delivery system directed toward theloading member while maintaining the position of the elongate memberuntil the sheath contacts the loading member. Another step 2322comprises applying an axial force on the elongate member directed awayfrom the storage member while maintaining the position of the sheathsuch that the elongate member is withdrawn from the loading member andthe medical device is advanced into the sheath. Another step 2324comprises removing the delivery system from the loading member.

Step 2302 can be accomplished by applying a force on a first capdirected away from a storage member such that the cap is removed fromthe storage member (e.g., axial force, rotational force). The type offorce will depend on the type of attachment between the cap and thestorage member.

Step 2304 can be accomplished in any suitable manner, such as byapplying a force on a diffuser directed away from a storage member inembodiments in which the diffuser is releasably disposed within astorage member. Alternatively, in embodiments in which a diffuser ispermanently attached, or releasably attached, to a cap, step 2304 can beaccomplished concurrently with step 2302.

Step 2306 can be accomplished by applying a force on a device guarddirected toward the storage member until the device guard is attached tothe storage member. Step 2306 can be accomplished using any suitabledevice guard, such as the device guards described herein. In analternative embodiment, step 2306 can be omitted from a method ofloading an implantable medical device onto a delivery system.

Step 2308 can be accomplished by applying a force on a second capdirected away from a storage member such that the cap is removed fromthe storage member (e.g., axial force, rotational force). The type offorce will depend on the type of attachment between the cap and thestorage member.

Step 2310 can be accomplished by applying a force on a storage memberdirected toward a loading member until the storage member is attached tothe loading member, applying a force on a loading member directed towarda storage member until the storage member is attached to the loadingmember, or applying a force on a storage member directed toward aloading member and applying a force on a loading member directed towarda storage member until the storage member is attached to the loadingmember. FIGS. 46 and 46A illustrate a storage member 2330 attached to aloading member 2332 of a guide system 2334.

Step 2312 can be accomplished using any suitable delivery system, suchas the delivery systems described herein. Step 2312 can be accomplishedby maintaining the position of a sheath and applying an axial force onan elongate member directed toward a loading member until the elongatemember is passed through the storage member, the loading member, and ispartially disposed (e.g., tip) within the device guard.

Step 2314 can be accomplished by applying a force on a loading pullerdirected toward an elongate member of a delivery system until theloading puller is disposed within the notch defined by the elongatemember. FIGS. 47 and 47A illustrate a delivery system 2336 partiallydisposed within the device guard 2338 and the loading puller 2340disposed within the notch 2342 defined by the elongate member 2344.FIGS. 48 and 48A illustrate the loading puller 2340 in the openconfiguration, free of the implantable medical device, and disposedwithin the fourth portion of the loading member. In embodiments in whichloading puller 2752, as described in more detail herein, is beingutilized, another step comprises applying an axial force on each of thefirst and second portions directed initially toward the lengthwise axis2757 of the loading puller 2752 and, once the first and second portionspass the lengthwise axis 2757, away from the lengthwise axis 2757 tomove the loading puller to the open configuration.

Step 2318 can be accomplished by applying an axial force on the loadingpuller directed away from the delivery system until it is free of thedelivery system. FIGS. 49 and 49A illustrate the sheath advanced towardthe loading puller such that it contacts the loading member (e.g., itcontacts shoulder 1674 defined within passageway defined by the loadingmember, it contacts the second end of the loading member).

Step 2322 can optionally be accomplished using structure attached to, orseparate from, a loading member that provides for a releasableattachment between the loading member and a sheath during use such thatthe position of the sheath can be maintained while the elongate memberis being retracted into the sheath. For example, a loading member caninclude a collet, or flexible flaps, that extend into the passagewaydefined by the loading member that are sized and configured to mate witha sheath and maintain the position of the sheath until an axial force isapplied to the sheath to remove it from the loading member.

Step 2324 can be accomplished by applying an axial force on the deliverysystem directed away from the loading member until the delivery systemis free of the loading member. An optional step comprises implanting theimplantable medical device within a body of a patient. Another optionalstep comprises orienting the tip of the delivery system relative to theimplantable medical device using the device guard.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2300, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2000, examplemethod 2100, example method 2200, example method 2400, and/or examplemethod 2900.

FIG. 50 is a schematic illustration of another example method 2400 ofloading an implantable medical device onto a delivery system.

A step 2402 comprises removing a cap from a storage member containing animplantable medical device. Another step 2404 comprises removing adiffuser from the storage member. Another step 2406 comprises attachinga device guard to the storage member. Another step 2408 comprisesapplying an axial force on an elongate member of a delivery systemdirected toward the storage member while maintaining the position of asheath of the delivery system such that the elongate member is passedthrough the storage member and partially disposed within the deviceguard. Another step 2410 comprises positioning a loading puller within anotch defined by an elongate member of the delivery system. Another step2412 comprises applying an axial force on the elongate member of thedelivery system directed away from the loading member until the firstand second ends of the loading puller are disposed within the fourthportion of the loading member. Another step 2414 comprises removing theloading puller from the delivery system and loading member. Another step2416 comprises applying an axial force on a sheath of the deliverysystem directed toward the loading member while maintaining the positionof the elongate member until the sheath contacts the loading member.Another step 2418 comprises applying an axial force on the elongatemember directed away from the loading member while maintaining theposition of the sheath such that the elongate member is withdrawn fromthe loading member and the medical device is advanced into the sheath.Another step 2420 comprises removing the delivery system from theloading member.

Step 2404 can be accomplished as described above with respect to step2304. Step 2406 can be accomplished using any suitable device guard,such as the device guards described herein. In an alternativeembodiment, step 2406 can be omitted from a method of loading animplantable medical device onto a delivery system. Step 2408 can beaccomplished using any suitable delivery system, such as the deliverysystems described herein. Depending on the arrangement of the storagemember being used in a method of loading an implantable medical deviceonto a delivery system, an implantable medical device can be wet duringthe loading process. FIGS. 51 and 51A illustrate a delivery system 2422partially disposed within the device guard 2424 and the loading puller2426 disposed within the notch 2428 defined by the elongate member 2430.FIGS. 52 and 52A illustrate the loading puller 2426 in the openconfiguration. FIGS. 53 and 53A illustrate the sheath 2432 advancedtoward the loading member 2434 such that it contacts the loading member2434. When disposed within a delivery system, an implantable medicaldevice can be partially disposed on a gripping member and entirelydisposed proximal to a tip. An optional step comprises implanting theimplantable medical device within a body of a patient. Another optionalstep comprises orienting the tip of the delivery system relative to theimplantable medical device using the device guard. Another optional stepcomprises removing a second cap from the loading member to expose theloading puller.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2400, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2000, examplemethod 2100, example method 2200, example method 2300, and/or examplemethod 2900.

FIG. 54 illustrates another example delivery system 2510. The deliverysystem 2510 is similar to the delivery system 1410 illustrated in FIG.30 and described above, except as detailed below. The delivery system2510 includes a sheath 2512, an elongate member 2514, a tip 2516, agripping member 2560, and a pushing member 2570.

In the illustrated embodiment, the pushing member 2570 is partiallydisposed within the lumen 2526 defined by the sheath 2512 and has afirst end 2572, a second end 2574, a length 2575, and a main body 2576that defines a lumen 2578 that extends through the entire length 2575and is sized and configured to receive a portion of the elongate member2514. Optionally, the material forming a pushing member can include aradiopaque filled for improved visualization and/or a pushing member canbe sized and configured to receive a portion of a gripping member and/ora tip. The lumen 2526 defined by the sheath 2512 is sized and configuredto receive a portion of the elongate member 2514, the gripping member2560, an implantable medical device disposed on the elongate memberand/or gripping member, and a portion of the tip 2516. Alternativeembodiments, however, can include a sheath that defines a lumen that issized and configured such that it does not receive a portion of a tip.In use, when it is desired to deploy an implantable medical devicedisposed within the lumen 2526 defined by the sheath 2512, a userapplies an axial force on the sheath 2512 directed away from the tip2516 and toward the first end 2530 of the elongate member 2514 whilemaintaining the position of the elongate member 2514 and pushing member2570. Alternatively, a user applies an axial force on the elongatemember 2514 and the pushing member 2570 directed toward the sheath whilemaintaining the position of the sheath 2512. Once the second end 2522 ofthe sheath 2512 is positioned at a point between the gripping member2560 and the notch 2542, a user can either maintain the position of thepushing member 2570 and apply an axial force on the elongate member 2514directed away from the sheath such that the tip 2516 is advanced towardthe second end 2522 of the sheath 2512 or apply an axial force on thepushing member 2570 directed toward the tip while maintaining theposition of the elongate member 2514 such that the second end 2574 ofthe pushing member 2570 is advanced toward the tip 2516, or beyond thesecond end 2548 of the tip 2516. This provides a mechanism fordelivering the implantable medical device at a point of treatment.

FIG. 55 illustrates an alternative device guard 2615 that can be usedwith a loading member, such as loading member 1614, or any othersuitable loading member, as described in more detail herein. The deviceguard 2615 has a first end 2656, a second end 2658, and a main body 2660that defines a base 2662, a first projection 2664, a second projection2666, a third projection 2668, and a passageway 2670. Each of the firstprojection 2664 and the second projection 2666 extends from the base2662 to the second end 2658 of the device guard 2615. The thirdprojection 2668 extends from the base 2662 toward the second end 2658 toan end 2672 and has a lengthwise axis 2673. In the illustratedembodiment, the third projection 2668 has a length that is less than thelength of each of the first and second projections 2664, 2666. Whendevice guard 2615 is attached to a loading member (e.g., loading member2814), the lengthwise axis 2673 of the third projection 2668 is coaxialwith the axis of the passageway defined by the loading member. Each ofthe first and second projections 2664, 2666 are disposed on a plane thatdoes not contact the lengthwise axis 2673. However, alternativeembodiments can include first and second projections that are disposedon a plane that contains, or contacts, the lengthwise axis of a thirdprojection and/or that have a length that is equal to, or less than, thelength of a third projection. The main body 2660 defines the passageway2670 through the base 2662 and the third projection 2668. The passageway2670 is sized and configured to receive a portion of a delivery system(e.g., elongate member, tip), as described in more detail herein. Anysuitable structure can be included on a device guard, such as deviceguard 2615, to accomplish releasable attachment to the device guard,such as snap fit connections, and any other structure consideredsuitable for a particular embodiment, such as those described herein.

FIGS. 56 and 57 illustrate an example loading assister 2710. The loadingassister 2710 has a first end 2712, a second end 2714, a shaft 2716, anda hook 2718.

The shaft 2716 has a first end 2720, a second end 2722, and a main body2724 that defines a first portion 2726 and a second portion 2728. Thefirst portion 2726 has a width 2727, a length 2729, and a thickness2731. The second portion 2728 has a width 2733, a length 2735, and athickness 2737. The thickness 2737 of the second portion 2728 is equalto the thickness 2731 of the first portion 2726. The width 2733 of thesecond portion 2728 is less than the width 2727 of the first portion2726 and is sized and configured to be received by a passageway definedby a loading member and/or first and second tracks defined by a loadingmember (e.g., first and second tracks 1090, 1092, first and secondtracks 1658, 1662, first and second tracks 2858, 2862). The length 2733of the second portion 2728 is greater than the length 2729 of the firstportion 2726 and greater than the length of the passageway defined by aloading member (e.g., passageway 1032, passageway 1656, passageway2856). In the illustrated embodiment, the width 2731 of the secondportion 2728 is less than the width 1671 of the fourth portion of apassageway defined by a loading member (e.g., fourth portion 1040 of thepassageway 1032, fourth portion 1670 of the passageway 1656, fourthportion 2870 of the passageway 2856) and less than the distance betweenthe base of a first track and the base of a third track along the thirdportion of a passageway of a loading member (e.g., base 1651 of thefirst track 1658 and the base 1651 of the third track 1662 along thethird portion 1668 of the passageway 1656). The thickness 2737 of thesecond portion 2728 is less than the thickness of each of the first andthird tracks of a loading member (e.g., first and third tracks 1658,1662) defined by the loading member 1614. This structural arrangementprovides a mechanism for the loading assister to be advanced through,and withdrawn from, the passageway defined by a loading member.

The hook 2718 is a separate component attached to the second end 2722 ofthe shaft 2716 and has a first end 2740, a second end 2742, and a mainbody 2744 that defines a curve 2746 and a recess 2748. The curve 2746 isdefined between the first and second ends 2740, 2742. The recess 2748extends from the second end 2742 and away from the first end 2740 and issized and configured to receive a portion of a loading puller (e.g.,portion between third bend 668 and fourth bend 670 of loading puller652, curve 2768), such as those described herein.

While the loading assister 2710 has been illustrated as having aparticular structural arrangement, and as having a hook attached to ashaft, a loading assister can have any suitable structural arrangement.Selection of a suitable structural arrangement can be based on variousconsiderations, such as the structural arrangement of a loading memberthrough which a loading assister is intended to be passed. For example,a loading assister can define a shaft that has a first portion andsecond portion that have the same, or different, lengths, width, and/orthicknesses, a hook attached to any suitable portion of a shaft, and/ora hook that is formed from the material that forms the shaft (e.g., suchthat a shaft and hook are formed as a single, unitary component).

FIGS. 58, 59, and 60 illustrated another example loading puller 2752.The loading puller 2752 is similar to the loading puller 652 illustratedin FIGS. 16, and 16A and described above, except as detailed below.

In the illustrated embodiment, The loading puller 2752 has a lengthwiseaxis 2757, a first end 2758, a second end 2760, a length 2761, a firstportion 2763, a second portion 2765, and main body 2762 that defines afirst bend 2764, a second bend 2766, a curve 2768, a third bend 2770,and a fourth bend 2772. The first bend 2764 is positioned near the firstend 2758 between the first end 2758 and the second bend 2766 and thefourth bend 2772 is positioned near the second end 2760 between thesecond end 2760 and the third bend 2770 such that the loading pullerdefines two hooked ends 2774, 2776 that are adapted to partiallysurround a portion of a frame of an implantable medical device when theloading puller 2752 is releasably attached to the implantable medicaldevice. The second bend 2766 is disposed between the first bend 2764 andthe curve 2768 and the third bend 2770 is disposed between the curve2768 and the fourth bend 2772 such that the loading puller 2752 definesa u-shaped member 2778 that include portions crossing one another.

The loading puller 2752 is adapted to be disposed within a loadingmember and is moveable between a first, closed configuration, as shownin FIGS. 58 and 59, and a second, open configuration, as shown in FIG.60. The loading puller 2752 is biased to the closed configuration. Inthe closed configuration, the first portion 2763 overlaps the secondportion 2765 such that the hooked end 2772, 2774 are directed away fromone another. In the open configuration, the first portion 2763 does notoverlap with the second portion 2765 and the hooked end 2772, 2774 aredirected toward one another such that the first hooked end 2774 isopposably positioned from the second hooked end 2776 relative to thelengthwise axis 2757 of the loading puller 2752. Movement of the loadingpuller 2752 from the closed to open configuration can be accomplished byapplying an axial force on each of the first and second portionsdirected initially toward the lengthwise axis 2757 of the loading puller2752 and, once the first and second portions pass the lengthwise axis2757, directed away from the lengthwise axis 2757. To attach the loadingpuller 2752 to an implantable medical device 2780, as shown in FIG. 60,the loading puller 2752 is moved to the open configuration such that theloading puller 2752 has a width disposed between the hooked ends 2772,2774 that is greater than the outside diameter of the implantablemedical device 2780. The loading puller 2752 is then advanced toward theimplantable medical device and the axial forces are removed from thefirst and second portions 2763, 2765 such that the loading puller 2752is releasably attached to the implantable medical device 2780 and thewidth disposed between the hooked ends 2772, 2774 that is less than theoutside diameter of the implantable medical device 2780. When attachedto the implantable medical device 2780, a portion of the loading puller2752 (e.g., hooked ends 2772, 2774) is disposed within one or moreopenings 2781 defined by a frame of the implantable medical device 2780,such that the loading puller 2752 is capable of applying axial force onthe implantable medical device 2780 when axial force is applied to theloading puller 2752 along its lengthwise axis 2757. Removal of theloading puller 2752 from releasable attachment to the implantablemedical device 2780, as shown in FIG. 60, can be accomplished byapplying an axial force on each of the first and second portions 2763,2765 directed away from the lengthwise axis 2757 until the loadingpuller 2752 becomes free of the implantable medical device 2780. Aloading puller, such as those described herein can optionally bepre-attached to an implantable medical device (e.g., sterilizedimplantable medical device), sterilized, and/or disposed within a liquidmaterial (e.g., holding material) within a sealed package. The loadingpuller 2752 provides a mechanism for maintaining attachment between theloading puller 2752 and an implantable medical device during use untilan external force is applied to the loading puller 2752 and/or theimplantable medical device.

FIGS. 61, 62, 63, 64, 65, and 66 illustrate another example loadingmember 2814. The loading member 2814 is similar to the loading member1614 illustrated in FIGS. 33, 35, and 35A and described above, except asdetailed below.

In the illustrated embodiment, the loading member 2814 is formed as asingle, unitary component. The loading member 2814 has a lengthwise axis2844, a first end 2846, a second end 2848, and a main body 2850 thatdefines a first opening 2852, a second opening 2854, a passageway 2856,a first track 2858, a second track 2860, a third track 2862, a fourthtrack 2877, and guide passageways 2865. The passageway 2856 extends fromthe first opening 2852 to the second opening 2854 and has a firstportion 2864, a second portion 2866, a third portion 2868, a fourthportion 2870, and a fifth portion 2872. Each of the first track 2858 andthe third track 2862 has a thickness 2853. Each of the second track 2860and fourth track 2877 extends from the first end 2846 toward the fifthportion 2872 to a location within the third portion 2868. Each of thefirst track 2858 and third track 2862 is sized and configured to receivea portion of a loading assister and/or loading puller and provides amechanism to guide the loading assister and/or loading puller throughthe loading member 2814 during use. Each of the guide passageways 2865extends from the first end 2846, into the main body 2850, toward thesecond end 2848, and is sized and configured to receive a projection(e.g., a first projection 2664, a second projection 2666) defined by adevice guard (e.g., device guard 2615) to achieve alignment and/orreleasable attachment between the loading member 2814 and the deviceguard.

FIG. 67 is a schematic illustration of another example method 2900 ofloading an implantable medical device onto a delivery system.

A step 2902 comprises obtaining an implantable medical device with anattached loading puller. Another step 2904 comprises removing theimplantable medical device and loading puller from the container.Another step 2906 comprises rinsing the implantable medical device andloading puller. Another step 2908 comprises advancing a loading assisterthrough a passageway defined by a loading member. Another step 2910comprises attaching the loading assister to the loading puller. Anotherstep 2912 comprises withdrawing the loading assister from the loadingmember. Another step 2914 comprises removing the loading assister fromthe loading puller. Another step 2916 comprises attaching a device guardto the loading member. Another step 2918 comprises applying an axialforce on an elongate member of a delivery system directed toward aloading member such that it is passed through the loading member andpartially disposed within the device guard. Another step 2920 comprisespositioning a loading puller within a notch defined by an elongatemember of the delivery system. Another step 2922 comprises applying anaxial force on the elongate member of the delivery system directed awayfrom the loading member until the first and second ends of the loadingpuller are disposed within the fourth portion of the loading member.Another step 2924 comprises removing the loading puller from thedelivery system and loading member. Another step 2926 comprises applyingan axial force on a sheath of the delivery system directed toward theloading member while maintaining the position of the elongate memberuntil the sheath contacts the loading member (e.g., is disposed withinthe loading member and contacts a portion (e.g., shoulder) of theloading member). Another step 2928 comprises applying an axial force onthe elongate member directed away from the loading member whilemaintaining the position of the sheath such that the elongate member iswithdrawn from the loading member and the medical device is advancedinto the sheath. Another step 2930 comprises removing the deliverysystem from the loading member.

Step 2902 can be accomplished by obtaining any suitable implantablemedical device having any suitable pre-attached loading puller, such asloading puller 2752 and implantable medical device 2780 illustrated inFIG. 60. An implantable medical device and pre-attached loading pullercan be disposed within a container filled with a holding material.Alternatively, step 2902 can comprise various separate steps thatcomprise obtaining an implantable medical device, removing theimplantable medical device from container, and attaching a loadingpuller to the implantable medical device. Alternatively, step 2902 canbe omitted from method 2900.

Step 2904 can be accomplished using any suitable method or technique ofremoving an implantable medical device and a pre-attached loading pullerfrom a container. Alternatively, step 2904 can be omitted from method2900.

Step 2906 can be accomplished using any method or technique of rinsingan implantable medical device and/or loading puller and any suitablerinsing material, such as those described herein. Alternatively, step2906 can be omitted from method 2900.

Step 2908 can be accomplished using any suitable loading assister, suchas loading assister 2710, and any suitable loading member, such as thosedescribed herein (e.g., loading puller 2814). Step 2908 can beaccomplished by applying an axial force on the loading assister directedtoward the passageway defined by a loading member while maintaining theposition of the loading member, or applying and axial force on theloading member directed toward the loading assister, until the secondend of the loading assister is passed through the passageway defined bythe loading member. Alternatively, step 2908 can be accomplished bymaintaining the position of the loading assister while applying an axialforce on a loading member toward the loading assister.

Step 2910 can be accomplished by advancing a portion of a loading puller(e.g., portion between second bend 666 and third bend 668 of loadingpuller 652, curve 2768 of loading puller 2752) into a recess defined bya loading assister (e.g., recess 2748). Optionally, step 2910 can beaccomplished such that the loading puller, loading assister, andimplantable medical device are positioned vertically. FIG. 68illustrates the loading assister 2710 illustrated in FIGS. 56 and 57advanced through the loading member 2814 illustrated in FIGS. 61, 62,63, 64, 65, and 66, the loading puller 2752 illustrated in FIGS. 58, 59,and 60 releasably attached to the loading assister 2710 (e.g., the curve2768 disposed within the recess 2748 defined by the loading assister2710) and free of the loading member 2814, and an implantable medicaldevice 2780 releasably attached to the loading puller 2752. In theillustrated embodiment, the loading member 2814 is formed from atransparent material.

Step 2912 can be accomplished by applying an axial force on the loadingassister directed away from the loading member while maintaining theposition of the loading member, or applying and axial force on theloading member directed away from the loading assister, until the secondend of the loading assister is passed through the passageway defined bythe loading member and the loading assister is free of the loadingmember. Alternatively, step 2912 can be accomplished by maintaining theposition of the loading assister while applying an axial force on aloading member away from the loading assister. Optionally, step 2912 canbe accomplished such that the loading puller, loading assister, andimplantable medical device are positioned vertically. FIG. 69illustrates the loading assister 2710 withdrawn from the loading member2814 such that it is free of the loading member 2814, the loading puller2752 releasably attached to the loading assister 2710 and partiallydisposed within the loading member 2814, and an implantable medicaldevice 2780 releasably attached to the loading puller 2752 and entirelydisposed within the loading member 2814.

Step 2914 can be accomplished by withdrawing the portion of the loadingpuller (e.g., portion between second bend 666 and third bend 668 ofloading puller 652, curve 2768 of loading puller 2752) from the recessdefined by a loading assister (e.g., recess 2748). FIG. 70 illustratesthe loading puller 2752 free of a loading assister and partiallydisposed within the loading member 2814 and an implantable medicaldevice 2780 releasably attached to the loading puller 2752 and entirelydisposed within the loading member 2814.

Step 2916 can be accomplished using any suitable device guard, such asthe device guards described herein (e.g., device guard 2615). Step 2916can be accomplished by applying an axial force on the device guarddirected toward the loading member while maintaining the position of theloading member, or applying and axial force on the loading memberdirected toward the device guard, until the device guard is releasablyattached to the loading member (e.g., the first and second projections2664, 2666 are disposed within guide passageways 2865). Alternatively,step 2916 can be accomplished by maintaining the position of the deviceguard while applying an axial force on a loading member toward thedevice guard. FIG. 70 illustrates the device guard 2615 attached to theloading member 2814.

Step 2918 can be accomplished using any suitable delivery system, suchas the delivery systems described herein (e.g., delivery system 2510).Step 2918 can be accomplished by applying an axial force on a portion ofthe delivery system (e.g., elongate member 2514) directed toward thepassageway defined by a loading member while maintaining the position ofthe remaining portions of the delivery system (e.g., sheath, pushingmember) and loading member, or applying and axial force on the loadingmember directed toward the portion of the delivery system (e.g.,elongate member), until the second end of the elongate member is passedthrough the passageway defined by the loading member. Alternatively,step 2918 can be accomplished by maintaining the position of a portionof the delivery system (e.g., elongate member) while applying an axialforce on a loading member toward the loading assister.

Step 2920 can be accomplished by applying a force on the loading pullerdirected toward the notch defined by an elongate member of a deliverysystem until the loading puller (e.g., curve 2768) is disposed withinthe notch. FIG. 71 illustrates the delivery system 2510 partiallydisposed within the device guard 2615 and the loading member 2814 andthe loading puller 2752 disposed within the notch 2542 defined by theelongate member 2514. In addition, FIG. 71 illustrates the loadingpuller 2752 partially disposed within the loading member 2814 and animplantable medical device 2780 releasably attached to the loadingpuller 2752 and entirely disposed within the loading member 2814.

Step 2922 can be accomplished by applying an axial force on the elongatemember directed away from the loading member while maintaining theposition of the loading member, or applying and axial force on theloading member directed away from the elongate member, until the firstand second ends of the loading puller are disposed within the fourthportion of the loading member. Alternatively, step 2922 can beaccomplished by maintaining the position of the elongate member whileapplying an axial force on a loading member away from the elongatemember. As the implantable medical device is being compressed in theloading member, a portion, or the entirety, of the implantable medicaldevice is collapsed onto the gripping member providing friction betweenthe gripping member and the implantable medical device.

In embodiments in which loading puller 2752 is being used in method2900, step 2924 can be accomplished by applying an axial force on eachof the first and second portions 2763, 2765 directed away from thelengthwise axis 2757 until the loading puller 2752 becomes free of theimplantable medical device 2780 and subsequently applying an axial forceon the loading puller directed away from the loading member. Inembodiments in which loading puller 652 is being utilized in method2900, step 2924 can be accomplished by applying an axial force on theloading puller directed away from the loading member.

While various steps, alternative steps, and optional steps have beendescribed above with respect to the example method 2900, these steps,alternative steps, and optional steps can be included in, accomplishedconcurrently with, and/or accomplished in the alternative to, themethod, steps, alternative steps, and/or optional steps described hereinwith respect to the example method 1900, example method 2000, examplemethod 2100, example method 2200, example method 2300, and/or examplemethod 2400.

The example storage devices, loading devices, guide systems, deliverysystems, loading pullers, and methods described herein provide amechanism for decreasing the complexity of sterilizing, storing,rinsing, and/or loading implantable medical devices and minimizing therisk associated with handling an implantable medical device that isintended for implantation. For example, the example storage devices,loading devices, guide systems, delivery systems, and methods describedherein provide a mechanism for sterilizing, storing, rinsing, and/orloading an implantable medical device using a closed system that reducesthe interaction with the implantable medical device duringsterilization, storing, rinsing, and/or loading.

Those with ordinary skill in the art will appreciate that variousmodifications and alternatives for the described and illustratedembodiments can be developed in light of the overall teachings of thedisclosure. Accordingly, the particular arrangements disclosed areintended to be illustrative only and not limiting as to the scope of theinvention, which is to be given the full breadth of the appended claimsand any and all equivalents thereof.

What is claimed is:
 1. A storage device for a medical device, thestorage device comprising: a storage member having a first end, a secondend, and a main body defining a first opening, a second opening, apassageway, a separating wall, and a plurality of holes, the passagewayextending from the first opening to the second opening and having afirst portion and a second portion, the separating wall extending intothe passageway at a location between the first end and the second end,the first portion of the passageway extending from the first end of thestorage member to the separating wall and the second portion of thepassageway extending from the second end of the storage member to theseparating wall, the second portion being sized and configured to housesaid medical device, each hole of the plurality of holes extendingthrough the separating wall and providing access between the firstportion of the passageway and the second portion of the passageway; afirst cap releasably attached to the first end of the storage member;and a second cap releasably attached to the second end of the storagemember.
 2. The storage device of claim 1, wherein the separating wall ispositioned closer to the first end than the second end.
 3. The storagedevice of claim 1, wherein the first portion of the passageway has afirst inside diameter; wherein the second portion of the passageway hasa second inside diameter at the separating wall that is less than thefirst inside diameter and a third inside diameter at the second end thatis greater than the second inside diameter such that the second portiontapers from the second end to the separating wall.
 4. The storage deviceof claim 3, wherein the separating wall defines a through hole having aninside diameter that is less than the second inside diameter.
 5. Thestorage device of claim 1, wherein the first cap comprises a deviceguard partially extending into the passageway defined by the storagemember.
 6. The storage device of claim 5, wherein the device guard has afirst end, a second end, and a main body defining a base, a firstprojection, a second projection, and a recess, the base disposed betweenthe first end of the device guard and the second end of the device guardand sized and configured to be releasably attached within the passagewaydefined by the storage member, the first projection extending from thebase to the first end and the second projection extending from the baseto the second end, the recess extending from the first end toward thesecond end to a recess base.
 7. The storage device of claim 5, whereinthe device guard has a first end, a second end, and a main body defininga base, a sidewall, a projection, and a recess extending into theprojection, the base and the sidewall cooperatively defining a cavitysized and configured to receive a portion of the storage member, theprojection extending from the base through the cavity, and to the secondend of the device guard, the recess extending from the second end andinto the projection.
 8. The storage device of claim 1, wherein the mainbody of the storage member defines a circumferential wall; and whereineach hole of the plurality of holes is equally spaced from an adjacenthole of the plurality of holes and is disposed the same distance fromthe circumferential wall relative to the other holes of the plurality ofholes.
 9. The storage device of claim 1, wherein the main body of thestorage member defines a circumferential wall; and wherein the main bodyof the storage member defines a plurality of recesses, each recess ofthe plurality of recesses extending into the circumferential wall to arecess base and extending from the separating wall toward the second endof the storage member, each recess of the plurality of recesses is incommunication with a hole of the plurality of holes.
 10. The storagedevice of claim 9, wherein each recess of the plurality of recesses hasa first width at the separating wall at the recess base and a secondwidth between the separating wall and the second end at the recess basethat is greater than the first width.
 11. The storage device of claim 1,further comprising an implantable medical device disposed within thestorage member.
 12. The storage device of claim 11, wherein theimplantable medical device is disposed within the second portion of thepassageway defined by the storage member.
 13. A storage device for amedical device, the storage device comprising: a storage member having afirst end, a second end, and a main body defining a first opening, asecond opening, a passageway, a separating wall, and a plurality ofholes, the passageway extending from the first opening to the secondopening and having a first portion and a second portion, the separatingwall extending into the passageway at a location between the first endand the second end, the first portion of the passageway extending fromthe first end of the storage member to the separating wall and thesecond portion of the passageway extending from the second end of thestorage member to the separating wall, the second portion being sizedand configured to house said medical device, each hole of the pluralityof holes extending through the separating wall and providing accessbetween the first portion of the passageway and the second portion ofthe passageway; a first cap releasably attached to the first end of thestorage member; and a second cap releasably attached to the second endof the storage member, second cap having a first end, a second end, anda main body defining a passageway that has a first portion, a secondportion, and a third portion, the first portion of the passageway of thesecond cap extending from the first end of the second cap toward thesecond end of the second cap and having a first inside diameter, thesecond portion of the passageway of the second cap extending from thefirst portion to the third portion and having a second inside diameterthat tapers from the first portion of the passageway of the second capto the third portion of the passageway of the second cap.
 14. Thestorage device of claim 13, wherein the first cap has a main bodydefining a passageway that extends through the first cap; wherein thepassageway of the second cap extends through the second cap; and furthercomprising a first one-way valve attached to the first cap and a secondone-way valve attached to the second cap.
 15. The storage device ofclaim 13, further comprising a diffuser disposed within the firstportion of the passageway defined by the storage member, the diffuserhaving a first end, a second end, a base, and a frame, the baseextending from the second end of the diffuser toward the first end ofthe diffuser to the frame, the frame extending from the base to thefirst end of the diffuser and having a plurality of struts that define aplurality of openings.
 16. The storage device of claim 13, furthercomprising an implantable medical device disposed within the storagemember.
 17. The storage device of claim 16, wherein the implantablemedical device is disposed within the second portion of the passagewaydefined by the storage member.
 18. The storage device of claim 16,further comprising a loading puller releasably attached to theimplantable medical device and partially disposed within each of thestorage member and the second cap, the loading puller having a firstend, a second end, a length, and main body defining a first bend, and asecond bend, the first bend positioned between the first end of theloading puller and the second bend, the second bend positioned betweenthe second end of the loading puller and the first bend such that theloading puller defines two hooked ends that partially surround a portionof the implantable medical device.
 19. A loading device for a medicaldevice, the loading device comprising: a storage member having a firstend, a second end, and a main body defining a first opening, a secondopening, a passageway, a separating wall, and a plurality of holes, thepassageway extending from the first opening to the second opening andhaving a first portion and a second portion, the separating wallextending into the passageway at a location between the first end andthe second end, the first portion of the passageway extending from thefirst end of the storage member to the separating wall and the secondportion of the passageway extending from the second end of the storagemember to the separating wall, the second portion being sized andconfigured to house said medical device, each hole of the plurality ofholes extending through the separating wall and providing access betweenthe first portion of the passageway and the second portion of thepassageway; a first cap releasably attached to the first end of thestorage member; a loading member releasably attached to the second endof the storage member, the loading member having a first end, a secondend, and a main body defining a first opening, a second opening, and apassageway extending from the first opening to the second opening, thepassageway of the loading member having a first portion, a secondportion, a third portion, and a fourth portion, the first portion of thepassageway of the loading member extending from the first end of theloading member to the second portion of the passageway of the loadingmember and having a first inside diameter, the second portion of thepassageway of the loading member extending from the first portion of thepassageway of the loading member to the third portion of the passagewayof the loading member and having a second inside diameter that tapersfrom the first portion of the passageway of the loading member to thethird portion of the passageway of the loading member, the third portionof the passageway of the loading member extending from the secondportion of the passageway of the loading member to the fourth portion ofthe passageway of the loading member and having a third inside diameterthat is less than the first inside diameter of the first portion of thepassageway of the loading member; and a second cap releasably attachedto the second end of the loading member.
 20. The loading device of claim19, further comprising an implantable medical device disposed within thestorage member.
 21. The loading device of claim 20, wherein theimplantable medical device is disposed within the second portion of thepassageway defined by the storage member.
 22. The loading device ofclaim 20, further comprising a loading puller releasably attached to theimplantable medical device and partially disposed within each of thestorage member and the loading member, the loading puller having a firstend, a second end, a length, and main body defining a first bend, and asecond bend, the first bend positioned between the first end of theloading puller and the second bend, the second bend positioned betweenthe second end of the loading puller and the first bend such that theloading puller defines two hooked ends that partially surround a portionof the implantable medical device.
 23. A loading device for a medicaldevice, the loading device comprising: a loading member having a firstend, a second end, and a main body defining a first opening, a secondopening, and a passageway extending from the first opening to the secondopening, the passageway having a first portion, a second portion, athird portion, and a fourth portion, the first portion of the passagewayextending from the first end to the second portion of the passageway andhaving a first inside diameter, the second portion of the passagewayextending from the first portion of the passageway to the third portionof the passageway and having a second inside diameter that tapers fromthe first portion of the passageway to the third portion of thepassageway, the third portion of the passageway extending from thesecond portion of the passageway to the second end and having a thirdinside diameter that is less than the first inside diameter of the firstportion of the passageway, the fourth portion of the passagewayextending from the third portion of the passageway to the second end andhaving a width that is greater than the third inside diameter of thethird portion of the passageway; a first cap releasably attached to thefirst end of the loading member; and a second cap releasably attached tothe second end of the loading member.
 24. The loading device of claim23, further comprising an implantable medical device disposed within theloading member.
 25. The loading device of claim 24, wherein theimplantable medical device is disposed within the first portion of thepassageway defined by the loading member.
 26. The loading device ofclaim 24, further comprising a loading puller releasably attached to theimplantable medical device and partially disposed within the passagewaydefined by the loading member and the second cap, the loading pullerhaving a first end, a second end, a length, and main body defining afirst bend, and a second bend, the first bend positioned between thefirst end of the loading puller and the second bend, the second bendpositioned between the second end of the loading puller and the firstbend such that the loading puller defines two hooked ends that partiallysurround a portion of the implantable medical device.